Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Inducti... | NCT02573493 | Trialant
NCT02573493
Sponsor
Washington University School of Medicine
Status
Completed
Last Update Posted
Dec 27, 2024Actual
Enrollment
96Actual
Phase
Phase 2
Conditions
Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell of the Head and Neck
Cancer of Head and Neck
Cancer of the Head and Neck
Head and Neck Cancer
Neoplasms, Head and Neck
Interventions
nab-Paclitaxel
Cisplatin
Cetuximab
Intensity-Modulated Radiation Therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02573493
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
201510013
Secondary IDs
Not provided
Brief Title
Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Official Title
Phase II Non-Randomized Three Arm Trial of Induction Chemotherapy With Nab-Paclitaxel and Cisplatin (AP: Arms 1 and 3) or Single Agent Nab-paclitaxel (A: Arm 2) as Induction Therapy Followed by Definitive Concurrent Chemoradiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC): "The APA Trial".
Acronym
APA
Organization
Washington University School of MedicineOTHER
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 13, 2016Actual
Primary Completion Date
Dec 12, 2019Actual
Completion Date
Jul 1, 2024Actual
First Submitted Date
Oct 7, 2015
First Submission Date that Met QC Criteria
Oct 7, 2015
First Posted Date
Oct 9, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 7, 2020
Results First Submitted that Met QC Criteria
Feb 27, 2021
Results First Posted Date
Mar 2, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 2, 2024
Last Update Posted Date
Dec 27, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Washington University School of MedicineOTHER
Collaborators
Name
Class
Celgene Corporation
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
In this trial, the objectives are to determine the efficacy and toxicity of induction chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and 5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in this cancer.
Amendment to Add Arm 3:
In this amendment, the investigators retain the AP + concurrent chemoradiation therapy (CRT) backbone but de-escalate the dose of radiation therapy (RT) from 70 Gy to 42 Gy. The investigators also plan to administer one dose (vs three) of cisplatin during RT. This novel treatment approach will be evaluated in patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) (Arm 3), a sub-group with a very favorable prognosis.
Detailed Description
Not provided
Conditions Module
Conditions
Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell of the Head and Neck
Cancer of Head and Neck
Cancer of the Head and Neck
Head and Neck Cancer
Neoplasms, Head and Neck
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
96Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1: nab-Paclitaxel and cisplatin (AP) + CRT
Experimental
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
Drug: nab-Paclitaxel
Drug: Cisplatin
Radiation: Intensity-Modulated Radiation Therapy
Arm 2: nab-Paclitaxel (A) + CRT
Experimental
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Drug: nab-Paclitaxel
Biological: Cetuximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
nab-Paclitaxel
Drug
Arm 1: nab-Paclitaxel and cisplatin (AP) + CRT
Arm 2: nab-Paclitaxel (A) + CRT
Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRT
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note.
Completion of treatment (estimated to be 11-15 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note.
Partial response - 99-50% decrease
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria: Arms 1 and 3 - AP
Diagnosis of selected Stage III or IVa/b HNSCC. Arm 1: T2-T4 primary tumors. Arm 3: T2T1-T4 primary tumors. Although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible.
Arm 1: Presence of disease at the oropharynx, hypopharynx, or larynx sub-sites.
Arm 3: Presence of disease at the oropharynx sub-sites, which is HPV-related as verified by p16, a surrogate marker of HPV, or HPV ISH or PCR.
Presence of measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
At least 18 years of age.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an IRB-approved written informed consent document.
ECOG performance status ≤ 1.
Adequate bone marrow and organ function as defined below:
ANC: ≥ 1500/mcL.
Platelets: > 100,000/mcL.
Hemoglobin > 9.0 g/dL
Total bilirubin ≤ 1.5 mg/dL
AST/ALT/alkaline phosphatase: ≤ 2.5 x ULN.
Serum creatinine: < 1.5 mg/dL or calculated GFR ≥ 75 cc/min. CrCl by Cockcroft Gault will be used to estimate GFR.
Pulmonary: no requirement for supplemental oxygen and no evidence of moderate-severe chronic obstructive pulmonary disease (COPD) by pulmonary function tests (PFTs).
Inclusion Criteria: Arm 2 - A
Diagnosis of selected Stage III or IVa/b HNSCC. T2-T4 primary tumors. (Patients with T1 tumors will be excluded). Although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible.
Presence of disease at the oropharynx, hypopharynx, or larynx sub-sites.
Presence of measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
At least 18 years of age.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an IRB-approved written informed consent document.
ECOG performance status < 3.
Adequate bone marrow and organ function as defined below:
ANC: ≥ 1500/mcL.
Platelets: ≥ 100,000/mcL.
Hemoglobin > 9.0 g/dL
Total bilirubin ≤ 2.0 mg/dL
AST/ALT/alkaline phosphatase: ≤ 5x ULN.
Calculated GFR >30 cc/min. CrCl by Cockcroft Gault will be used to estimate GFR.
Pulmonary: patients with a requirement for supplemental oxygen or evidence of moderate-severe COPD by PFTs are permitted to enroll.
If a patient fully meets criteria for Arm 1, but has profound hearing loss and the physician feels that the patient should not receive Cisplatin, the patient will be eligible for Arm 2.
If a patient fully meets criteria for Arm 1, but has a history of solid organ or bone marrow transplant, the patient will be eligible for Arm 2 (due to contraindications of Cisplatin with medications the patient is taking due to the transplant).
Exclusion Criteria (Arm 1 and Arm 2)
Prior chemotherapy, prior EGFR targeted therapy, or prior radiation therapy for HNSCC.
Disease at the nasopharyngeal, sinus, oral cavity, or other sub-site not specified as eligible.
Diagnosis of unknown primary squamous cell carcinoma of the head and neck.
History of prior invasive malignancy diagnosed within 3 years prior to study enrollment; exceptions are malignancies with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
Receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in this study.
Taking cimetidine or allopurinol. If currently taking either of these medications, patient must discontinue for one week before receiving treatment with nab-paclitaxel.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or serious psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant and/or breastfeeding. A negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential.
Known to be HIV-positive on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Peripheral neuropathy > grade 1.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Douglas Adkins, M.D.
Washington University School of Medicine
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The University of Kansas Cancer Center and Medical Pavilion
Oppelt P, Ley J, Daly M, Rich J, Paniello R, Jackson RS, Pipkorn P, Liu J, Gay H, Palka K, Neupane P, Powell S, Spanos WC, Gitau M, Zevallos J, Thorstad W, Adkins D. nab-Paclitaxel and cisplatin followed by cisplatin and radiation (Arm 1) and nab-paclitaxel followed by cetuximab and radiation (Arm 2) for locally advanced head and neck squamous-cell carcinoma: a multicenter, non-randomized phase 2 trial. Med Oncol. 2021 Mar 8;38(4):35. doi: 10.1007/s12032-021-01479-w.
See Also Links
Label
URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 25, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Radiation: Intensity-Modulated Radiation Therapy
Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRT
Experimental
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Drug: nab-Paclitaxel
Drug: Cisplatin
Radiation: Intensity-Modulated Radiation Therapy
Abraxane
Cisplatin
Drug
Arm 1: nab-Paclitaxel and cisplatin (AP) + CRT
Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRT
cis-DDP
cis-Platinum II
cis-Diamminedichloroplatinum
DDP
Cetuximab
Biological
Arm 2: nab-Paclitaxel (A) + CRT
Erbitux®
Intensity-Modulated Radiation Therapy
Radiation
Arm 1: nab-Paclitaxel and cisplatin (AP) + CRT
Arm 2: nab-Paclitaxel (A) + CRT
Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRT
IMRT
Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note.
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note.
Partial response - 99%-50% decrease
Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria
-Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response.
Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Document and Quantify Ki-67 Expression by IHC in Primary Tumor Tissue and Correlate With Clinical Primary Tumor Site Response
Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%).
30 days after completion of treatment (estimated to be 15-25 weeks)
Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4
-The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms.
Baseline and one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N
-The FACT-H&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head & neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life.
Baseline and one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from date of diagnosis to late date alive or time of death from any cause.
Through one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from date of diagnosis to last date alive or time of death from any cause.
Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
DFS: duration of time from last date of treatment to time of disease progression or death from any cause.
Through one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
DFS: duration of time from last date of treatment to time of disease progression or death from any cause.
Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
â—¦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.
Through one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
â—¦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.
Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note.
Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events
30 days after completion of treatment (estimated to be 15-25 weeks)
Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1
From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1
From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from start of treatment to time of death from any cause
Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
â—¦PFS: duration of time from start of treatment to time of progression or death, whichever occurs first.
Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Washington University School of Medicine
St Louis
Missouri
63110
United States
Sanford Cancer Center
Sioux Falls
South Dakota
57104
United States
FG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
FG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
FG003
Not Enrolled in Any Arm
-Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.
FG00040 subjects
FG00140 subjects
FG00215 subjects
FG0031 subjects
COMPLETED
FG00040 subjects
FG00140 subjects
FG00215 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Type
Comment
Reasons
Determined to not be eligible after enrollment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
BG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
BG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
BG003
Not Enrolled in Any Arm
-Determined to be not eligible after enrollment to study and was therefore not enrolled on any study arm.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00140
BG00215
BG0031
BG00496
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00057.5(42 to 77)
BG00165.5(48 to 83)
BG00261(41 to 68)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00040
BG00140
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note.
Only participants enrolled in Arm 1 and Arm 2 are evaluable for this outcome measure.
Posted
Count of Participants
Participants
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG0020
Title
Denominators
Categories
Title
Measurements
OG00028
OG0018
Primary
Arm 3: Median Percent Weight Loss
Only participants enrolled in Arm 3 are evaluable for this outcome measure.
Posted
Median
Full Range
percentage of weight loss
Completion of treatment (estimated to be 11-15 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Secondary
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note.
Partial response - 99-50% decrease
Posted
Count of Participants
Participants
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Secondary
Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note.
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Secondary
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note.
Partial response - 99%-50% decrease
Posted
Count of Participants
Participants
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria
-Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response.
Posted
Count of Participants
Participants
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Document and Quantify Ki-67 Expression by IHC in Primary Tumor Tissue and Correlate With Clinical Primary Tumor Site Response
The data was not collected for this outcome measure.
Posted
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Secondary
Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%).
Posted
Count of Participants
Participants
30 days after completion of treatment (estimated to be 15-25 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) Induction
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction
Secondary
Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4
-The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline and one year after completion of treatment (approximately 74 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N
-The FACT-H&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head & neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline and one year after completion of treatment (approximately 74 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from date of diagnosis to late date alive or time of death from any cause.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of particpants
Through one year after completion of treatment (approximately 74 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from date of diagnosis to last date alive or time of death from any cause.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
DFS: duration of time from last date of treatment to time of disease progression or death from any cause.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through one year after completion of treatment (approximately 74 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
DFS: duration of time from last date of treatment to time of disease progression or death from any cause.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
â—¦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through one year after completion of treatment (approximately 74 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
â—¦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Secondary
Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note.
Only participants enrolled in Arm 3 are evaluable for this outcome measure.
Posted
Count of Participants
Participants
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
Secondary
Arm 1 and Arm 3: Comparison of Response Rate
-Stratified for HPV status
Data was not collected for this outcome measure.
Posted
Completion of 2 cycles (approximately 6 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Secondary
Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events
Posted
Count of Participants
Participants
30 days after completion of treatment (estimated to be 15-25 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT
OG002
Arm 1 CRT: Cisplatin + Radiation Therapy
CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.
It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Secondary
Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1
Posted
Median
Full Range
kilograms
From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Secondary
Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1
Posted
Median
Inter-Quartile Range
median percent of weight loss
From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from start of treatment to time of death from any cause
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
â—¦PFS: duration of time from start of treatment to time of progression or death, whichever occurs first.
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Secondary
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
Posted
Number
percentage of participants
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
Secondary
Arm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Secondary
Arm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Secondary
Arm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival
2 participants were excluded in Arm 3 because they received full dose radiation therapy instead of reduced dose radiation therapy.
Posted
Number
percentage of participants
Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
ID
Title
Description
OG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
OG001
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Time Frame
-Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment).
Description
-Participants at risk is zero for Other (Not Including Serious) Adverse Events for Arm 1 Follow-up, Arm 2 Follow-up, and Arm 3 Follow-up because adverse events were not collected in the follow-up period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction
Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment
If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT)
If \
0
40
6
40
40
40
EG001
Arm 2: Nab-Paclitaxel (A) Induction
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
0
40
6
40
40
40
EG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT
0
15
2
15
15
15
EG003
Arm 1 CRT: Cisplatin + Radiation Therapy
CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.
It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
0
34
9
34
34
34
EG004
Arm 1 & 2 ERT: Cetuximab + Radiation Therapy
CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.
It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
0
42
6
42
42
42
EG005
Arm 3 CR: Cisplatin + Radiation Therapy
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
0
15
2
15
15
15
EG006
Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up
-Follow-up time period of up to 72 months post-completion of therapy
9
40
0
40
0
0
EG007
Arm 2: Nab-Paclitaxel + ERT Follow-up
-Follow-up time period of up to 72 months post-completion of therapy
21
40
1
40
0
0
EG008
Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up
-Follow-up time period of up to 72 months post-completion of therapy
4
15
1
15
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
EG0041 affected42 at risk
EG0050 affected15 at risk
EG00640 at risk
EG0070 affected40 at risk
EG0080 affected15 at risk
Catheter related infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Thrombosis/embolism
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Creatinine
Investigations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Syncope
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Febrile neutropenia
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Sepsis
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Renal failure
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Fever
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Agitation
Psychiatric disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Blood infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Death NOS
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Cardiac/heart pain
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Confusion
Nervous system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Fatigue
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Hypertension
Vascular disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Bladder obstruction
Renal and urinary disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Cellulitis
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0021 affected15 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Throat/pharynx/larynx pain
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Allergic reaction - cetuximab
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Chest/thorax pain
Respiratory, thoracic and mediastinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Anxiety
Psychiatric disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Malabsorption
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Fracture
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Death due to disease progression NOS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0013 affected40 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
EG0044 affected42 at risk
EG0051 affected15 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
Cardiac ischemia/infarction
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Carotid artery stenosis
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Congestive heart failure
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Coronary artery disease
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0016 affected40 at risk
EG0020 affected15 at risk
EG003
Mitral valve prolapse
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Sick sinus syndrome
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Sinus bradycardia
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Sinus tachycardia
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG00011 affected40 at risk
EG0015 affected40 at risk
EG0020 affected15 at risk
EG003
Systolic murmur
Cardiac disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Ear pain
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0008 affected40 at risk
EG0013 affected40 at risk
EG0020 affected15 at risk
EG003
Hearing (with baseline audiogram)
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Hearing (without monitoring program)
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG00114 affected40 at risk
EG0021 affected15 at risk
EG003
Middle ear pain
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Tinnitus
Ear and labyrinth disorders
CTCAE (3.0)
Systematic Assessment
EG00011 affected40 at risk
EG0012 affected40 at risk
EG0026 affected15 at risk
EG003
Hyperthyroidism
Endocrine disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Corneal abrasion
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Eye pain
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Eyelid dysfunction
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Eyelid swelling
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Glaucoma
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Subconjuctival sclera hemorrhage
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Vision photophobia
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Watery eyes
Eye disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Colitis
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Colon polyps
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG00014 affected40 at risk
EG00114 affected40 at risk
EG0028 affected15 at risk
EG003
Dental/teeth/periodontal pain
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG00012 affected40 at risk
EG0017 affected40 at risk
EG0028 affected15 at risk
EG003
Distension/bloating
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0014 affected40 at risk
EG0024 affected15 at risk
EG003
Dysgeusia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0007 affected40 at risk
EG0014 affected40 at risk
EG0029 affected15 at risk
EG003
Dyspepsia/heartburn
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0012 affected40 at risk
EG0023 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG00020 affected40 at risk
EG00125 affected40 at risk
EG0026 affected15 at risk
EG003
GERD
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0006 affected40 at risk
EG0014 affected40 at risk
EG0020 affected15 at risk
EG003
Ileus
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Malabsorption
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Mucositis oral
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG00018 affected40 at risk
EG00114 affected40 at risk
EG00212 affected15 at risk
EG003
Odynophagia
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0013 affected40 at risk
EG0020 affected15 at risk
EG003
Oral cavity hemorrhage
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Oral cavity pain
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Oropharyngeal erythema
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Salivary gland changes/saliva
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Stoma hemorrhage
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Stomach stricture
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Stomatitis (oral cavity)
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Teeth (dental caries)
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0015 affected40 at risk
EG0021 affected15 at risk
EG003
Cervical adenopathy
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Face pain
General disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Fatigue
General disorders
CTCAE (3.0)
Systematic Assessment
EG00024 affected40 at risk
EG00121 affected40 at risk
EG00210 affected15 at risk
EG003
Fever
General disorders
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0012 affected40 at risk
EG0022 affected15 at risk
EG003
Flu-like syndrome
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
General edema
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Head and neck edema
General disorders
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0013 affected40 at risk
EG0021 affected15 at risk
EG003
Limb edema
General disorders
CTCAE (3.0)
Systematic Assessment
EG0005 affected40 at risk
EG0018 affected40 at risk
EG0021 affected15 at risk
EG003
Obesity
General disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Pain - NOS
General disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Pain in bottoms of feet
General disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Rigors/chills
General disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0013 affected40 at risk
EG0020 affected15 at risk
EG003
Agammaglobulinemia
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Allergic reaction
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Allergic reaction - cetuximab
Immune system disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Bacteremia
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Blood infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Catheter related infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Cellulitis
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Febrile neutropenia
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Lung infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Oral thrush
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Paronychia
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Shingles
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Skin infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0014 affected40 at risk
EG0020 affected15 at risk
EG003
Tooth infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Upper airway NOS infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0021 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0022 affected15 at risk
EG003
Viral hepatitis
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0015 affected40 at risk
EG0020 affected15 at risk
EG003
Viral respiratory infection
Infections and infestations
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Bruising
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Dermatitis - chemoradiation
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Dermatitis - chemotherapy
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Fracture
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
G-tube pain
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Induration
Injury, poisoning and procedural complications
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
ALT
Investigations
CTCAE (3.0)
Systematic Assessment
EG0007 affected40 at risk
EG0018 affected40 at risk
EG0021 affected15 at risk
EG003
AST
Investigations
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0019 affected40 at risk
EG0021 affected15 at risk
EG003
Alkaline phosphatase
Investigations
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0016 affected40 at risk
EG0021 affected15 at risk
EG003
Cardiac troponin I
Investigations
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Creatinine
Investigations
CTCAE (3.0)
Systematic Assessment
EG0009 affected40 at risk
EG00114 affected40 at risk
EG0022 affected15 at risk
EG003
Hemoglobin
Investigations
CTCAE (3.0)
Systematic Assessment
EG00040 affected40 at risk
EG00135 affected40 at risk
EG00215 affected15 at risk
EG003
Hyperbilirubinemia
Investigations
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0021 affected15 at risk
EG003
Hypercholesterolemia
Investigations
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
INR
Investigations
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0015 affected40 at risk
EG0021 affected15 at risk
EG003
Leukocytes
Investigations
CTCAE (3.0)
Systematic Assessment
EG00027 affected40 at risk
EG00125 affected40 at risk
EG00212 affected15 at risk
EG003
Lymphopenia
Investigations
CTCAE (3.0)
Systematic Assessment
EG00024 affected40 at risk
EG00125 affected40 at risk
EG0028 affected15 at risk
EG003
Neutropenia (ANC)
Investigations
CTCAE (3.0)
Systematic Assessment
EG00027 affected40 at risk
EG00121 affected40 at risk
EG00213 affected15 at risk
EG003
PTT
Investigations
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Platelets
Investigations
CTCAE (3.0)
Systematic Assessment
EG00016 affected40 at risk
EG0013 affected40 at risk
EG0021 affected15 at risk
EG003
Weight loss
Investigations
CTCAE (3.0)
Systematic Assessment
EG0008 affected40 at risk
EG0019 affected40 at risk
EG0024 affected15 at risk
EG003
Acidosis
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0008 affected40 at risk
EG0017 affected40 at risk
EG0023 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected40 at risk
EG0022 affected15 at risk
EG003
Diabetes
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0005 affected40 at risk
EG0019 affected40 at risk
EG0022 affected15 at risk
EG003
GFR
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Hypercalcemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0002 affected40 at risk
EG0013 affected40 at risk
EG0020 affected15 at risk
EG003
Hyperglycemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0008 affected40 at risk
EG0019 affected40 at risk
EG0021 affected15 at risk
EG003
Hyperkalemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0005 affected40 at risk
EG00110 affected40 at risk
EG0022 affected15 at risk
EG003
Hyperlipidemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0003 affected40 at risk
EG0013 affected40 at risk
EG0024 affected15 at risk
EG003
Hypermagnesemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Hypernatremia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Hypertriglyceridemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Hyperuricemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Hypoalbuminemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0009 affected40 at risk
EG00112 affected40 at risk
EG0021 affected15 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG00010 affected40 at risk
EG0016 affected40 at risk
EG0020 affected15 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0005 affected40 at risk
EG0015 affected40 at risk
EG0022 affected15 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0016 affected40 at risk
EG0022 affected15 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG00011 affected40 at risk
EG00114 affected40 at risk
EG0022 affected15 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Armpit pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0014 affected40 at risk
EG0020 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0011 affected40 at risk
EG0021 affected15 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Extremity muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Extremity/limb pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0022 affected15 at risk
EG003
Gout
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Jaw pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Joint pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected40 at risk
EG0022 affected15 at risk
EG003
Joint-function
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Knee pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Kyphosis
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Leg cramps
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0021 affected15 at risk
EG003
Lower extremity muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Lower limb generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected40 at risk
EG0020 affected15 at risk
EG003
Muscle pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected40 at risk
EG0020 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0005 affected40 at risk
EG0014 affected40 at risk
EG0020 affected15 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Shoulder pain
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Soft tissue necrosis - neck
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected40 at risk
EG0020 affected15 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
CTCAE (3.0)
Systematic Assessment
EG0007 affected40 at risk
EG0016 affected40 at risk
EG0020 affected15 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG0000
OG0010
OG00215
Title
Denominators
Categories
Title
Measurements
OG0026.7(2.2 to 12.9)
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00215
Title
Denominators
Categories
Title
Measurements
OG00011
OG00128
OG0026
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00030
OG00133
OG00211
Title
Denominators
Categories
Title
Measurements
OG00018
OG00114
OG0023
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00030
OG00133
OG00211
Title
Denominators
Categories
Title
Measurements
OG00011
OG00114
OG0027
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00139
OG00215
Title
Denominators
Categories
Complete response
Title
Measurements
OG0002
OG0011
OG0021
Partial response
Title
Measurements
OG00022
OG00120
OG00213
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG0000
OG0010
OG0020
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT
OG003
Arm 1 CRT: Cisplatin + Radiation Therapy
CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation.
It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
OG004
Arm 1 & 2 ERT: Cetuximab + Radiation Therapy
CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m^2 for seven additional doses concurrently with radiation therapy.
It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
OG005
Arm 3 CR: Cisplatin + Radiation Therapy
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00215
OG00339
OG00435
OG00515
Title
Denominators
Categories
Title
Measurements
OG00023
OG00117
OG0024
OG00337
OG00435
OG0054
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00139
OG00215
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000.19(0.02 to 0.36)
OG0010.38(0.18 to 0.59)
OG0020.27(0.04 to 0.57)
End of treatment
Title
Measurements
OG0001.55(1.09 to 2.01)
OG0010.91(0.40 to 1.33)
OG0021.54(0.90 to 2.18)
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00139
OG00215
Title
Denominators
Categories
Baseline
Title
Measurements
OG0002.02(1.93 to 2.11)
OG0011.86(1.74 to 1.97)
OG0022.07(1.94 to 2.20)
End of treatment
Title
Measurements
OG0001.98(1.89 to 2.06)
OG0011.82(1.71 to 1.93)
OG0022.00(1.86 to 2.15)
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG000100
OG00187.50
OG00292.31
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00097.44
OG00169.63
OG00284.62
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00087.50
OG00162.50
OG00276.92
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00087.50
OG00151.81
OG00269.23
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00092.50
OG00167.50
OG00276.92
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00087.43
OG00154.89
OG00269.23
OG001
Arm 2: Nab-Paclitaxel (A) + CRT
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG0000
OG0010
OG00215
Title
Denominators
Categories
Title
Measurements
OG0029
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Arm 3 CR: Cisplatin + Radiation Therapy
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00115
OG00239
OG00315
Title
Denominators
Categories
Title
Measurements
OG00023
OG0014
OG00237
OG0034
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00039
OG00135
OG00215
Title
Denominators
Categories
Title
Measurements
OG0008.4(3.1 to 20.8)
OG0015.2(4.9 to 14.6)
OG0027.0(1.7 to 12.8)
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00215
Title
Denominators
Categories
Title
Measurements
OG0009.1(6.7 to 11.2)
OG0016.6(2.6 to 8.1)
OG0026.7(2.2 to 9.9)
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00077.1
OG00140.5
OG00268.4
Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment
If CR/PR, three more weeks of nab-paclitaxel followed by CRT
If \
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Units
Counts
Participants
OG00040
OG00140
OG00213
Title
Denominators
Categories
Title
Measurements
OG00077.2
OG00133.8
OG00269.2
OG002
Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
6 weeks of nab-paclitaxel and cisplatin (days 1 & 22) followed by primary tumor site assessment
If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab
If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab
CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy
Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.