Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Slow accrual and funding issues
Expanded Access Info
No
Start Date
Jan 10, 2013Actual
Primary Completion Date
Oct 18, 2019Actual
Completion Date
Oct 18, 2019Actual
First Submitted Date
Sep 13, 2012
First Submission Date that Met QC Criteria
Sep 13, 2012
First Posted Date
Sep 18, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 16, 2020
Results First Submitted that Met QC Criteria
Oct 16, 2020
Results First Posted Date
Nov 10, 2020Actual
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
Nov 10, 2020
Last Update Posted Date
Nov 25, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Washington University School of MedicineOTHER
Collaborators
Name
Class
The Foundation for Barnes-Jewish Hospital
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Yes
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
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
Detailed Description
Not provided
Conditions Module
Conditions
Oropharyngeal Neoplasms
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
42Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Radiotherapy
Experimental
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Number of Participants With Disease-free Survival (DFS)
1 year
Locoregional Control
Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
Up to 2 years
Secondary Outcomes
Measure
Description
Time Frame
Rate of Distant Metastasis
Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
Up to 2 years
Disease Specific Survival
1 year
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC).
Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).
Patient's disease must be pathological N-stage positive.
Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review.
Patients with synchronous primaries are included.
Patients with unknown primaries are included if the diagnosis and resection of a primary site in the oropharynx is made from an endoscopic or robotic surgical procedure(s).
Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread.
Patient must be ≥ 21 years of age.
ECOG performance status ≤ 2 (Karnofsky ≥60%).
Patients must have normal organ and marrow function as defined below:
leukocytes ≥3,000/mcL
absolute neutrophil count ≥1,500/mcL
platelets ≥100,000/mcL
total bilirubin <1.5 X upper normal institutional limit
AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
Patient must not have pathologically N stage negative disease.
Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied.
Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil).
Patient must not have distant metastatic disease at presentation.
Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report.
Patient must not have transoral robotic surgery (TORS) for a T3 or T4 primary tumor.
Patient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago.
Patient must not have had previous systemic chemotherapy for the study cancer. (Note: prior chemotherapy for a different cancer is allowable).
Patient must not be receiving any other investigational agents.
Patient must not have had any prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/ unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements.
Patient must not be pregnant or breastfeeding. If a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception.
Both men and women and members of all races and ethnic groups are eligible for this trial.
Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
See Also Links
Label
URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
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
Oct 22, 2019
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
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
Drug
Radiotherapy, cisplatin
CACP, CDDP, CPDD, DDP, Neoplatin
Number of Complications/Acute Toxicity by Organ Class
-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Approximately 18 weeks
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory
Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5
The lower the score the lower the quality of life
Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire
25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering
Answers range from 0 = never to 4 = very often
The higher the score the worse the cognitive failures the participant has experienced
Baseline, 1 month, 12 months, and 24 months
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)
-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).
Baseline, 12 months, and 24 months
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire
It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.
The higher the score the worse the participant's xerostomia
Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Hearing as Measured by Hearing Handicap Inventory - Adult
11 item questionnaire to identify issues with hearing
Answers are yes = 4, sometimes = 2, and no = 0
The higher the score the more issues the participant has with hearing
Baseline, 1 month, and 12 months
Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity
1 question that asks about taste acuity
Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity
The higher the score the worse the participant's taste acuity
Baseline, 1 month, 6 months, and 12 months
Change in Quality of Life as Measured by Speech Handicap Index
31 questions regarding participant's speech and the effects of speech on his/her life
The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4
The higher the score the worse the participant's speech is affecting his/her life
Baseline and 12 months
Change in Quality of Life as Measured by EORTC QLQ-C30
30 questions designed to assess the quality of life of cancer patients
The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life
The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life
Baseline, 1 month, 6 months, 12 months, and 24 months
St Louis
Missouri
63110
United States
FG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
FG00027 subjects
FG00115 subjects
COMPLETED
FG00026 subjects
FG00111 subjects
NOT COMPLETED
FG0001 subjects
FG0014 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
Not eligible
FG0000 subjects
FG0012 subjects
Patient withdrew before completing all radiotherapy
FG0001 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
BG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00115
BG00242
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
BG00056(41 to 74)
BG00155(32 to 74)
BG00256(32 to 74)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
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
BG00027
BG00115
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
Number of Participants With Disease-free Survival (DFS)
Posted
Count of Participants
Participants
1 year
ID
Title
Description
OG000
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
Title
Denominators
Categories
Title
Measurements
OG00024
OG00110
Primary
Locoregional Control
Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
Posted
Count of Participants
Participants
Up to 2 years
ID
Title
Description
OG000
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Secondary
Rate of Distant Metastasis
Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
Posted
Count of Participants
Participants
Up to 2 years
ID
Title
Description
OG000
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Secondary
Disease Specific Survival
Posted
Count of Participants
Participants
1 year
ID
Title
Description
OG000
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
Secondary
Number of Complications/Acute Toxicity by Organ Class
-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
One participant in each Arm did not have adverse events collected.
Posted
Number
number of adverse events
Approximately 18 weeks
ID
Title
Description
OG000
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory
Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5
The lower the score the lower the quality of life
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 1 month, 6 months, 12 months, and 24 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Cognitive Function as Measured by Cognitive Failures Questionnaire
25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering
Answers range from 0 = never to 4 = very often
The higher the score the worse the cognitive failures the participant has experienced
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 1 month, 12 months, and 24 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)
-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 12 months, and 24 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire
It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.
The higher the score the worse the participant's xerostomia
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 1 month, 6 months, 12 months, and 24 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Hearing as Measured by Hearing Handicap Inventory - Adult
11 item questionnaire to identify issues with hearing
Answers are yes = 4, sometimes = 2, and no = 0
The higher the score the more issues the participant has with hearing
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 1 month, and 12 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity
1 question that asks about taste acuity
Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity
The higher the score the worse the participant's taste acuity
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 1 month, 6 months, and 12 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Quality of Life as Measured by Speech Handicap Index
31 questions regarding participant's speech and the effects of speech on his/her life
The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4
The higher the score the worse the participant's speech is affecting his/her life
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline and 12 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Secondary
Change in Quality of Life as Measured by EORTC QLQ-C30
30 questions designed to assess the quality of life of cancer patients
The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life
The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life
Some participants were not analyzed as the participants did not complete the questionnaires.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 1 month, 6 months, 12 months, and 24 months
ID
Title
Description
OG000
Baseline - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG001
Baseline - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Time Frame
Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)
Description
Not provided
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
Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
1
27
0
27
26
27
EG001
Radiotherapy, Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Title
Measurements
OG0001
OG0010
Nervous system disorders
Title
Measurements
OG00048
OG00129
Psychiatric disorders
Title
Measurements
OG00016
OG0019
Respiratory, thoracic and mediastinal disorders
Title
Measurements
OG00034
OG00114
Skin and subcutaneous tissue disorders
Title
Measurements
OG00032
OG00114
Surgical and medical procedures
Title
Measurements
OG0003
OG0010
Vascular disorders
Title
Measurements
OG00011
OG0016
OG002
1 Month - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
1 Month - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
6 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
6 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG006
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG007
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG008
24 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG009
24 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00023
OG00111
OG00222
OG00311
OG00413
OG0057
OG00615
OG0077
OG00817
OG0098
Title
Denominators
Categories
My swallowing ability limits my day to day activities.
Title
Measurements
OG0003.2608696± 1.3888318
OG0014.0000000± 1.0954451
OG0024.1818182± 1.2203186
OG0034.1818182± 1.1677484
OG0044.3076923± 0.9473309
OG0053.5714286± 1.5118579
OG0064.5000000± 0.6504436
OG0073.2857143± 1.6035675
OG0083.9375000± 1.3889444
OG0094.6250000± 0.5175492
I am embarrassed by my eating habits.
Title
Measurements
OG0003.5454545± 1.2993505
OG0014.4545455± 0.8201995
OG0024.1818182± 1.2587357
OG003
Swallowing is more difficult at the end of the day.
Title
Measurements
OG0003.3636364± 1.4974726
OG0014.5454545± 0.6875517
OG0023.8095238± 1.3273676
OG003
I do not feel self-conscious when I eat.
Title
Measurements
OG0003.3913043± 1.3395769
OG0014.0909091± 1.2210279
OG0023.9090909± 1.1087999
OG003
I am upset by my swallowing problem.
Title
Measurements
OG0003.2272727± 1.6599431
OG0012.0909091± 1.5135749
OG0022.8636364± 1.6123173
OG003
People have difficulty cooking for me.
Title
Measurements
OG0003.2173913± 1.5062452
OG0013.9090909± 1.2210279
OG0023.7727273± 1.3777766
OG003
Swallowing takes great effort.
Title
Measurements
OG0003.0869565± 1.5049326
OG0013.4545455± 1.2135598
OG0023.9545455± 1.0455016
OG003
I do not go out because of my swallowing problem.
Title
Measurements
OG0003.9130435± 0.9960396
OG0014.6363636± 0.5045250
OG0024.3181818± 0.9454837
OG003
My swallowing difficulty has caused me to lose income.
Title
Measurements
OG0004.2608696± 1.0538842
OG0013.9090909± 1.7002674
OG0024.5000000± 0.7400129
OG003
It takes me longer to eat because of my swallowing problem.
Title
Measurements
OG0002.5909091± 1.4690162
OG0012.4000000± 1.4298407
OG0023.1818182± 1.5625487
OG003
People ask me, "Why can't you eat that?"
Title
Measurements
OG0004.0869565± 1.1246431
OG0014.0000000± 1.1547005
OG0024.0000000± 1.2344268
OG003
Other people are irritated by my eating problem.
Title
Measurements
OG0004.2608696± 0.8643122
OG0014.2727273± 1.0090500
OG0024.5454545± 0.7385489
OG003
OG002
1 Month - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
1 Month - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG006
24 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG007
24 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
OG00222
OG00311
OG00416
OG0057
OG00617
OG0078
Title
Denominators
Categories
Do you read something and find you haven't been thinking about it and must read it again?
Title
Measurements
OG0001.4166667± 0.9743076
OG0011.3636364± 1.2060454
OG0021.5454545± 1.0107646
OG0031.2727273± 0.7862454
OG0041.4666667± 0.9154754
OG0052.1666667± 1.1690452
OG0061.5625000± 0.7274384
OG0071.5714286± 1.1338934
Do you find you forget why you went from one part of the house to the other?
Title
Measurements
OG0001.2083333± 0.9770927
OG0011.0909091± 0.9438798
OG0021.2727273± 1.1621744
OG003
Do you fail to notice signposts on the road?
Title
Measurements
OG0000.6666667± 0.9168313
OG0010.3636364± 0.6741999
OG0020.7272727± 0.9847319
OG003
Do you find you confuse right and left when giving directions?
Title
Measurements
OG0000.3333333± 0.8681147
OG0010.2727273± 0.4670994
OG0020.4545455± 0.9116846
OG003
Do you bump into people?
Title
Measurements
OG0000.2500000± 0.5316095
OG0010.1818182± 0.4045199
OG0020.3636364± 0.6579517
OG003
Do you find you forget whether you've turned off a light or a fire or locked the door?
Title
Measurements
OG0000.9583333± 0.9990938
OG0010.6363636± 0.6741999
OG0020.8636364± 1.1252705
OG003
Do you fail to listen to people's names when you are meeting them?
Title
Measurements
OG0001.7083333± 1.3014763
OG0011.0909091± 1.3003496
OG0021.8181818± 1.0970247
OG003
Do you say something and realize afterwards that it might be taken as insulting?
Title
Measurements
OG0001.0000000± 1.0632191
OG0010.9090909± 0.8312094
OG0021.0000000± 1.1126973
OG003
Do you fail to hear people speaking to you when you are doing something else?
Title
Measurements
OG0001.3750000± 1.3772215
OG0011.2727273± 1.2720778
OG0021.4090909± 1.0980108
OG003
Do you lose your temper and regret it?
Title
Measurements
OG0000.9583333± 1.0417029
OG0011.0000000± 0.7745967
OG0021.0909091± 1.0649879
OG003
Do you leave important letters unanswered for days?
Title
Measurements
OG0000.6666667± 1.0772203
OG0010.6363636± 1.0269106
OG0021.0000000± 1.0235326
OG003
Do you find you forget which way to turn on a road you know well but rarely use?
Title
Measurements
OG0000.4782609± 0.9472239
OG0010.4545455± 0.8201995
OG0020.4090909± 0.9591212
OG003
Do you fail to see what you want in a supermarket (although it's there)?
Title
Measurements
OG0000.6250000± 0.7696696
OG0010.4545455± 0.5222330
OG0020.9090909± 1.0649879
OG003
Do you find yourself suddenly wondering whether you've used a word correctly?
Title
Measurements
OG0000.5833333± 0.7172815
OG0010.6363636± 0.6741999
OG0020.7727273± 1.0203556
OG003
Do you have trouble making up your mind?
Title
Measurements
OG0000.9583333± 1.0826363
OG0010.9090909± 1.0444659
OG0021.0000000± 1.1126973
OG003
Do you find you forget appointments?
Title
Measurements
OG0000.5833333± 0.9743076
OG0010.5454545± 0.6875517
OG0020.7727273± 1.1097755
OG003
Do you forget where you put something like a newspaper or a book?
Title
Measurements
OG0001.0416667± 0.8064504
OG0011.00000000± 0.8944272
OG0021.1363636± 1.0371873
OG003
Do you find you accidentally throw away the thing you want and keep what you meant to throw away?
Title
Measurements
OG0000.5416667± 1.0623668
OG0010.1818182± 0.4045199
OG0020.5454545± 1.0107646
OG003
Do you daydream when you out to be listening to something?
Title
Measurements
OG0001.1250000± 1.0347232
OG0011.2727273± 1.0090500
OG0021.1818182± 1.0064726
OG003
Do you find you forget people's names?
Title
Measurements
OG0001.8333333± 1.1671842
OG0011.6363636± 1.5015144
OG0021.8636364± 1.3556040
OG003
Do you start doing one thing at home and get distracted into doing something else (unintentionally)?
Title
Measurements
OG0001.2500000± 1.1887151
OG0011.0909091± 1.0444659
OG0021.5454545± 1.1843131
OG003
Do you find you can't quite remember something although it's on the tip of your tongue?
Title
Measurements
OG0001.4166667± 0.9743076
OG0011.4545455± 1.2135598
OG0021.8181818± 0.8528029
OG003
Do you find you forget what you came to the shops to buy?
Title
Measurements
OG0000.8333333± 0.8164966
OG0010.6363636± 0.8090398
OG0021.1363636± 0.9902118
OG003
Do you drop things?
Title
Measurements
OG0000.4583333± 0.7790276
OG0010.8181818± 0.6030227
OG0020.8181818± 1.0527227
OG003
Do you find you can't think of anything to say?
Title
Measurements
OG0000.7916667± 0.9315329
OG0010.5454545± 0.6875517
OG0020.8636364± 1.1252705
OG003
OG002
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
24 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
24 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00023
OG00111
OG00216
OG0037
OG00417
OG0058
Title
Denominators
Categories
Neck or shoulder pain or discomfort
Title
Measurements
OG0001.6086957± 1.1175920
OG0012.0909091± 1.2210279
OG0021.4666667± 0.9904304
OG0032.4285714± 1.5118579
OG0041.3125000± 0.8732125
OG0051.7500000± 1.2817399
Neck or shoulder stiffness
Title
Measurements
OG0001.4545455± 1.1433981
OG0012.0000000± 1.2649111
OG0021.0000000± 0.8451543
OG003
Difficulty with self-care activities because of neck or shoulder
Title
Measurements
OG0000.8695652± 0.9197009
OG0011.2727273± 1.1037127
OG0020.3333333± 0.8164966
OG003
Limited ability to life light objects because of your shoulder or neck
Title
Measurements
OG0000.6521739± 0.8846517
OG0011.6363636± 1.4333686
OG0020.4000000± 0.7367884
OG003
Limited ability to lift heavy objects because of your shoulder or neck
Title
Measurements
OG0001.6086957± 1.3395769
OG0012.2727273± 1.4206273
OG0020.5333333± 0.9904304
OG003
Limited ability to reach for objects because of your shoulder or neck
Title
Measurements
OG0001.2173913± 1.3802675
OG0012.0909091± 1.5135749
OG0020.5333333± 0.8338094
OG003
Overall activity level because of your shoulder or neck
Title
Measurements
OG0001.0000000± 1.2431631
OG0011.9090909± 1.5782614
OG0020.5333333± 0.8338094
OG003
Has the treatment of your neck affected your participation in social activities?
Title
Measurements
OG0000.7391304± 1.1368774
OG0010.9090909± 1.2210279
OG0020.0666667± 0.2581989
OG003
Limited in ability to do leisure or recreational activities because of your neck or shoulder?
Title
Measurements
OG0001.0869565± 1.3788349
OG0011.7272727± 1.4893562
OG0020.2000000± 0.5606119
OG003
Limited in ability to do work including work at home because of neck or shoulder discomfort or pain?
Title
Measurements
OG0001.1304348± 1.3916749
OG0011.7272727± 1.6180797
OG0020.2666667± 0.5936168
OG003
OG002
1 Month - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
1 Month - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
6 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
6 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG006
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG007
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG008
24 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG009
24 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
OG00221
OG00311
OG00414
OG0057
OG00617
OG0077
OG00817
OG0098
Title
Denominators
Categories
Rate your difficulty in talking due to dryness
Title
Measurements
OG0002.3333333± 2.4788964
OG0011.3636364± 2.2033033
OG0022.8095238± 2.9089353
OG0033.9090909± 2.3855626
OG0043.0000000± 2.9612887
OG0054.8571429± 3.2366944
OG0062.5625000± 2.8276905
OG0073.5714286± 3.2071349
OG0083.6875000± 2.9825884
OG0093.1250000± 2.7998724
Rate your difficulty chewing due to dryness
Title
Measurements
OG0002.3913043± 2.2711457
OG0011.4545455± 2.5831623
OG0023.5238095± 2.6947922
OG003
Rate your difficulty in swallowing solid food due to dryness
Title
Measurements
OG0002.6956522± 2.6532104
OG0011.6363636± 2.8380531
OG0023.4285714± 2.5994505
OG003
Rate the frequency of your sleeping problems due to dryness
Title
Measurements
OG0001.7916667± 1.8876985
OG0011.5454545± 2.8412545
OG0023.2857143± 2.9179249
OG003
Rate your mouth or throat dryness when eating food
Title
Measurements
OG0002.2173913± 2.1523037
OG0011.8181818± 3.0271499
OG0023.8571429± 2.9203718
OG003
Rate your mouth or throat dryness while not eating
Title
Measurements
OG0002.1250000± 2.1931217
OG0011.5454545± 2.3393861
OG0023.8571429± 2.7979584
OG003
Rate the frequency of sipping liquids to aid swallowing food
Title
Measurements
OG0003.1739130± 2.7741039
OG0012.2727273± 3.1013194
OG0025.1428571± 3.2293299
OG003
Rate the frequency of sipping liquids for oral comfort when not eating
Title
Measurements
OG0002.9565217± 2.7216015
OG0012.0909091± 2.8090762
OG0024.6190476± 3.3388050
OG003
OG002
1 Month - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
1 Month - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
OG00222
OG00311
OG00416
OG0057
Title
Denominators
Categories
Does a hearing problem cause you to feel embarrassed when you meet new people?
Title
Measurements
OG0000.2500000± 0.6079188
OG0010.5454545± 0.9341987
OG0020.2380952± 0.6248809
OG0030.1818182± 0.6030227
OG0040.1333333± 0.3518658
OG0051.0000000± 1.0000000
Does a hearing problem cause you to feel frustrated when talking to members of your family?
Title
Measurements
OG0000.1250000± 0.4484272
OG0010.1818182± 0.6030227
OG0020.5238095± 0.8728716
OG003
Do you have difficulty hearing or understanding co-workers or clients or customers?
Title
Measurements
OG0000.5000000± 0.8340577
OG0011.0909091± 1.0444659
OG0020.6666667± 0.9128709
OG003
Do you feel that any difficulty with your hearing limits or hampers your personal or social life?
Title
Measurements
OG0000.1666667± 0.4815434
OG0010.6363636± 0.9244163
OG0020.3809524± 0.7400129
OG003
Do you feel handicapped by a hearing problem?
Title
Measurements
OG0000.1250000± 0.4484272
OG0010.5454545± 0.9341987
OG0020.1428571± 0.4780914
OG003
Does a hearing problem cause you difficulty in the movies or in the theater?
Title
Measurements
OG0000.1666667± 0.4815434
OG0010.4545455± 0.8201995
OG0020.5238095± 0.8728716
OG003
Does a hearing problem cause you difficulty when in a restaurant with relatives or friends?
Title
Measurements
OG0000.2173913± 0.5997364
OG0010.7272727± 0.9045340
OG0020.6190476± 0.8646497
OG003
Does a hearing problem cause you to attend religious services less often than you would like?
Title
Measurements
OG0000.0416667± 0.2041241
OG0010.1818182± 0.6030227
OG0020.0000000± 0.0000000
OG003
Does a hearing problem cause you to have argments with family members?
Title
Measurements
OG0000.2500000± 0.6756639
OG0010.1818182± 0.6030227
OG0020.1000000± 0.4472136
OG003
Does a hearing problem cause you difficulty when listening to TV or radio?
Title
Measurements
OG0000.3750000± 0.7109364
OG0010.4545455± 0.8201995
OG0020.8571429± 0.9636241
OG003
Does a hearing problem cause you difficulty when visiting friends or relatives or neighbors?
Title
Measurements
OG0000.3333333± 0.7019641
OG0010.6363636± 0.9244163
OG0020.1904762± 0.5117663
OG003
OG002
1 Month - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
1 Month - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
6 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
6 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG006
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG007
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
OG00222
OG00311
OG00414
OG0057
OG00616
OG0077
Title
Denominators
Categories
Title
Measurements
OG0001.0833333± 1.1000659
OG0010.9090909± 0.8312094
OG0022.1363636± 1.0821255
OG0032.9090909± 1.0444659
OG0040.9285714± 0.7300459
OG0052.4285714± 0.9759001
OG0061.0000000± 0.7559289
OG0071.5714286± 0.7867958
OG002
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
OG00216
OG0037
Title
Denominators
Categories
My speech makes it difficult for people to understand me
Title
Measurements
OG0001.9565217± 1.0215078
OG0011.7272727± 0.9045340
OG0021.3333333± 0.6172134
OG0031.8333333± 1.3291601
I run out of air when I speak
Title
Measurements
OG0001.5000000± 0.7223151
OG0011.4545455± 0.6875517
OG0021.2666667± 0.7037316
OG003
The intelligibility of my speech varies throughout the day
Title
Measurements
OG0002.0000000± 1.0632191
OG0011.5454545± 0.8201995
OG0021.4000000± 0.7367884
OG003
My speech makes me feel incompetent
Title
Measurements
OG0001.3750000± 0.6468990
OG0011.2727273± 0.6466698
OG0021.1333333± 0.3518658
OG003
People ask me why I'm hard to understand
Title
Measurements
OG0001.2916667± 0.6240935
OG0011.1818182± 0.4045199
OG0021.1333333± 0.3518658
OG003
I feel annoyed when people ask me to repeat
Title
Measurements
OG0001.3750000± 0.8242256
OG0011.2727273± 0.6466698
OG0021.3333333± 0.4879500
OG003
I avoid using the phone
Title
Measurements
OG0001.6250000± 1.2091139
OG0011.5454545± 0.9341987
OG0021.1333333± 0.3518658
OG003
I'm tense when talking to others because of my speech
Title
Measurements
OG0001.4166667± 0.7172815
OG0011.5454545± 0.8201995
OG0021.0666667± 0.2581989
OG003
My articulation is unclear
Title
Measurements
OG0001.8333333± 0.9630868
OG0011.8181818± 1.3506205
OG0021.4666667± 0.7432234
OG003
People have difficulty understanding me in a noisy room
Title
Measurements
OG0001.8750000± 1.0347232
OG0011.8181818± 0.9816498
OG0021.6000000± 0.9856108
OG003
I tend to avoid groups of people because of my speech
Title
Measurements
OG0001.2500000± 0.6079188
OG0011.727277± 0.9045340
OG0021.2666667± 0.7988086
OG003
People seem irritated with my speech
Title
Measurements
OG0001.1250000± 0.3378320
OG0011.3636364± 0.5045250
OG0021.1333333± 0.3518658
OG003
People ask me to repeat myself when speaking face-to-face
Title
Measurements
OG0001.5416667± 0.7790276
OG0011.7272727± 0.9045340
OG0021.3333333± 0.4879500
OG003
I speak with friends and neighbors and relatives less often because of my speech
Title
Measurements
OG0001.4166667± 0.7172815
OG0011.2727273± 0.6466698
OG0021.2666667± 0.7988086
OG003
I feel ask though I have to strain to speak
Title
Measurements
OG0001.833333± 0.9630868
OG0011.9090909± 1.1361818
OG0021.2000000± 0.5606119
OG003
I find other people don't understand my speaking problem
Title
Measurements
OG0001.1666667± 0.3806935
OG0011.2727273± 0.6466698
OG0021.0666667± 0.2581989
OG003
My speaking difficulties restrict my person and social life
Title
Measurements
OG0001.3750000± 0.6468990
OG0011.2727273± 0.6466698
OG0021.2000000± 0.5606119
OG003
The intelligibility is unpredictable
Title
Measurements
OG0001.5833333± 0.8805466
OG0011.3636364± 0.8090398
OG0021.1333333± 0.3518658
OG003
I feel left out of conversations because of my speech
Title
Measurements
OG0001.2083333± 0.4148511
OG0011.3636364± 0.6741999
OG0021.3333333± 0.8164966
OG003
I use a great deal of effort to speak
Title
Measurements
OG0001.8750000± 0.9469631
OG0011.6363636± 0.9244163
OG0021.2666667± 0.4577377
OG003
My speech is worse in the evening
Title
Measurements
OG0001.6250000± 0.8753881
OG0011.6363636± 0.9244163
OG0021.3333333± 0.7237469
OG003
My speech problem causes me to lose income
Title
Measurements
OG0001.2916667± 0.6902531
OG0011.8181818± 1.2504545
OG0021.0000000± 0.0000000
OG003
I try to change my speech to sound different
Title
Measurements
OG0001.2916667± 0.8064504
OG0011.0909091± 0.3015113
OG0021.0666667± 0.2581989
OG003
My speech problem upsets me
Title
Measurements
OG0001.2083333± 0.4148511
OG0011.5454545± 0.8201995
OG0021.2666667± 0.4577377
OG003
I am less outgoing because of my speech problem
Title
Measurements
OG0001.2500000± 0.5316095
OG0011.4545455± 0.6875517
OG0021.0666667± 0.2581989
OG003
My family has difficulty understanding me when I call them throughout the house
Title
Measurements
OG0001.5000000± 0.7801895
OG0011.6363636± 0.8090398
OG0021.1333333± 0.5163978
OG003
My speech makes me feel handicapped
Title
Measurements
OG0001.3333333± 0.7019641
OG0011.4545455± 0.6875517
OG0021.0666667± 0.2581989
OG003
I have difficulties to continue a conversation because of my speech
Title
Measurements
OG0001.5000000± 0.7801895
OG0011.5454545± 0.8201995
OG0021.1333333± 0.3518658
OG003
I feel embarrassed when people ask me to repeat
Title
Measurements
OG0001.2083333± 0.5089774
OG0011.3636364± 0.9244163
OG0021.0000000± 0.0000000
OG003
I'm ashamed of my speech problem
Title
Measurements
OG0001.0833333± 0.2823299
OG0011.2727273± 0.9045340
OG0021.0000000± 0.0000000
OG003
How do you rate your own speech at this moment?
Title
Measurements
OG0002.1304348± 0.9678631
OG0011.4545455± 0.5222330
OG0021.3846154± 0.6504436
OG003
OG002
1 Month - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG003
1 Month - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG004
6 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG005
6 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG006
12 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG007
12 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG008
24 Months - Radiotherapy
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
OG009
24 Months - Radiotherapy + Cisplatin
Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
Units
Counts
Participants
OG00024
OG00111
OG00222
OG00311
OG00414
OG0057
OG00616
OG0077
OG00817
OG0098
Title
Denominators
Categories
Do you have trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase?
Title
Measurements
OG0002.0000000± 0.9534626
OG0012.0000000± 0.6324555
OG0021.7727273± 0.9223065
OG0031.4545455± 0.6875517
OG0041.3571429± 0.6333237
OG0051.7142857± 0.7559289
OG0061.2666667± 0.5936168
OG0071.5714286± 0.7867958
OG0081.4375000± 0.6291529
OG0091.6250000± 0.5175492
Do you have any trouble taking a long walk?
Title
Measurements
OG0001.7500000± 0.9440892
OG0011.0909091± 0.6015113
OG0021.3636364± 0.5810872
OG003
Do you have any trouble taking a short walk outside of the house?
Title
Measurements
OG0001.0833333± 0.2823299
OG0011.0000000± 0.0000000
OG0021.0454545± 0.2132007
OG003
Do you need to stay in bed or a chair during the day?
Title
Measurements
OG0001.4583333± 0.8329709
OG0011.0000000± 0.0000000
OG0021.2272727± 0.5284135
OG003
Do you need help with eating, dressing, washing yourself or using the toilet?
Title
Measurements
OG0001.0833333± 0.2823299
OG0011.0909091± 0.3015113
OG0021.0909091± 0.4264014
OG003
Were you limited in doing either your work or other daily activities?
Title
Measurements
OG0002.0833333± 1.0179548
OG0011.6363636± 1.0269106
OG0021.4090909± 0.7341397
OG003
Were you limited in pursuing your hobbies or other leisure time activities?
Title
Measurements
OG0002.0000000± 1.0215078
OG0011.6363636± 1.0269106
OG0021.4545455± 0.7385489
OG003
Were you short of breath?
Title
Measurements
OG0001.2916667± 0.6240935
OG0011.0000000± 0.0000000
OG0021.1363636± 0.3512501
OG003
Have you had pain?
Title
Measurements
OG0002.0000000± 0.7801895
OG0011.7272727± 0.7862454
OG0021.5000000± 0.5976143
OG003
Did you need to rest?
Title
Measurements
OG0001.9166667± 0.8805466
OG0011.5454545± 0.5222330
OG0021.5909091± 0.7341397
OG003
Have you had trouble sleeping?
Title
Measurements
OG0001.8333333± 0.8681147
OG0012.2727273± 1.1908744
OG0021.5454545± 0.6709817
OG003
Have you felt weak?
Title
Measurements
OG0001.9166667± 0.9743076
OG0011.8181818± 0.7507572
OG0021.6818182± 0.8387271
OG003
Have you lacked appetite?
Title
Measurements
OG0001.6956522± 0.8756703
OG0011.6363636± 0.9244163
OG0021.6363636± 0.7267314
OG003
Have you felt nauseated?
Title
Measurements
OG0001.1666667± 0.6370221
OG0011.3636364± 0.5045250
OG0021.1818182± 0.5010811
OG003
Have you vomited?
Title
Measurements
OG0001.0833333± 0.4082483
OG0011.0000000± 0.0000000
OG0021.0454545± 0.2132007
OG003
Have you been constipated?
Title
Measurements
OG0001.5000000± 0.7801895
OG0011.8181818± 1.0787198
OG0021.6363636± 0.7895420
OG003
Have you had diarrhea?
Title
Measurements
OG0001.0416667± 0.2041241
OG0011.1818182± 0.4045199
OG0021.1363636± 0.3512501
OG003
Were you tired?
Title
Measurements
OG0002.0000000± 0.8846517
OG0012.0000000± 0.7745967
OG0021.181818± 0.7950061
OG003
Did pain interfere with your daily activities?
Title
Measurements
OG0001.6666667± 0.8164966
OG0011.7272727± 0.6466698
OG0021.2380952± 0.6248809
OG003
Have you had difficulty in concentrating on things, like reading a newspaper or watching television
Title
Measurements
OG0001.4583333± 0.7790276
OG0011.2727273± 0.6466698
OG0021.2857143± 0.5606119
OG003
Did you feel tense?
Title
Measurements
OG0001.3750000± 0.6468990
OG0011.5454545± 0.6875517
OG0021.4090909± 0.5903262
OG003
Did you worry?
Title
Measurements
OG0001.9166667± 0.7755316
OG0012.0000000± 0.6324555
OG0021.4545455± 0.5958006
OG003
Did you feel irritable?
Title
Measurements
OG0001.4166667± 0.8297022
OG0011.5454545± 0.5222330
OG0021.4090909± 0.6661253
OG003
Did you feel depressed?
Title
Measurements
OG0001.5416667± 0.8836272
OG0011.4545455± 0.6875517
OG0021.3181818± 0.5679004
OG003
Have you had difficulty remembering things?
Title
Measurements
OG0001.4166667± 0.7172815
OG0011.2727273± 0.4670994
OG0021.5454545± 0.8004328
OG003
Has your physical condition or medical treatment interfered with your family life?
Title
Measurements
OG0001.7916667± 0.8836272
OG0011.5454545± 0.8201995
OG0021.3181818± 0.7162311
OG003
Has your physical condition or medical treatment interfered with your social activities?
Title
Measurements
OG0002.0416667± 0.9990938
OG0011.9090909± 1.0444659
OG0021.5909091± 0.7963662
OG003
Has your physical condition or medical treatment caused you financial difficulties?
Title
Measurements
OG0001.5416667± 1.0206207
OG0012.3636364± 1.2060454
OG0021.5909091± 0.9591212
OG003
How would you rate your overall health during the past week?
Title
Measurements
OG0005.2083333± 1.2846643
OG0015.2727273± 0.7862454
OG0025.4090909± 1.1815684
OG003
How would you rate your overall quality of life during the past week?