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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma.
The study regimen consists of cisplatin and radiation for all patients, the standard treatment for head and neck cancer. All patients will also receive pembrolizumab (the study drug), and will be randomized to two treatment schedules: either pembrolizumab with cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplating and radiation. |
|
| Arm 2 | Experimental | Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisp/radiation and given every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival at ≤12 Months | Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Up to 12 months |
| Progression-free Survival at ≤ 36 Months | Probability of participants (expressed as a percentage) without disease progression at less than or equal to 36 months after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Up to 36 months |
| Progression-free Survival at ≤ 48 Months | Probability of participants (expressed as a percentage) without disease progression time from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1: Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Up to 48 months |
| Acute Toxicity / DLT Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Median number of months from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1 Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Up to 48 months |
Not provided
Inclusion Criteria:
Written informed consent
If a woman of childbearing potential, documentation of negative pregnancy
Histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. The primary site may be the oral cavity, oropharynx, larynx, or hypopharynx. Patients with squamous cell carcinoma of unknown primary, metastatic to cervical lymph nodes, are permitted to enroll.
High risk or intermediate risk disease, defined below. Staging evaluation should be determined by imaging studies and complete head and neck exam in accordance with the American Joint committee on Cancer Staging Manual, 7th edition.
o High risk patient must meet one of the following criteria:
Surgically unresectable oral cavity. Patients who are technically resectable but refuse surgery due to morbidity (eg. total glossectomy) are also eligible. Medically inoperable patients are not eligible.
Larynx: T4 any N; T2-3 and ≥ N2a
Hypopharynx: T1-2N1-3 or T3-4N0-3
Oropharynx: p16(-) AND T3-4 or ≥ N2a
Unknown primary: p16(-) AND ≥ N2a
o Intermediate risk patients must meet one of the following criteria:
Oropharynx: p16(+) AND one of the following
T3 or ≥ N2a AND ≥ 10 pack-years tobacco exposure (see Tobacco Assessment Form, Appendix A)
T4 or N3 disease irrespective of tobacco exposure
Unknown primary: p16(+) AND one of the following
≥ N2a AND ≥ 10 pack-years tobacco exposure
N3 disease irrespective of tobacco exposure
Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor and/or nodal sites is permitted.
Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 differentiated thyroid carcinoma (resected or management deferred), who are eligible.
No prior systemic (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Age ≥ 18
Patients must have measurable disease according to RECIST 1.1
Patients must demonstrate adequate organ function as defined.
Sexually active patients must agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug.
Exclusion Criteria:
Nasopharyngeal primary site
Current participation in or previous participation in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent.
Distant metastatic disease including CNS or leptomeningeal metastases is not allowed.
History of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Received prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
History of second malignancy within 2 years prior to Study Day 1 (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, or T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection).
Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Received a live vaccine within 30 days prior to the first dose of trial treatment.
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Significant pulmonary disease, including pulmonary hypertension, interstitial lung disease, or active, non-infectious pneumonitis.
History or current evidence of any other medical or psychiatric condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Peripheral neuropathy ≥ Grade 2
Significant cardiovascular disease, including:
Significant thrombotic or embolic events within 3 months prior to Study Day 1.
Major surgery within 6 weeks prior to Study Day 1 (subjects must have completely recovered from any previous surgery prior to Study Day 1). Biopsy, diagnostic tonsillectomy, airway tumor debulking or excisional lymph node biopsy do not constitute major surgery.
Active infection requiring antibiotics or antifungals within 7 days prior to first dose of study drug.
Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):
Women must not be pregnant or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Zandberg, MD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40424564 | Derived | Zandberg DP, Vujanovic L, Clump DA, Isett BP, Wang H, Sica G, Bao R, Li H, Ohr J, Skinner HD, Seethala RR, Chiosea SI, Ferris RL, Bauman JE. Randomized Phase II Study of Concurrent Versus Sequential Pembrolizumab in Combination With Chemoradiation in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2025 Aug 10;43(23):2572-2582. doi: 10.1200/JCO-24-01580. Epub 2025 May 27. | |
| 35091445 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin + Radiation + Pembrolizumab - Concurrent | Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks. Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
| FG001 | Cisplatin + Radiation + Pembrolizumab - Sequential | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation. Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin + Radiation + Pembrolizumab - Concurrent | Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Progression-free Survival at ≤12 Months | Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | All patients that received treatment and were radiologically evaluable for response. | Posted | Number | percentage of patients | Up to 12 months |
|
Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin + Radiation + Pembrolizumab - Concurrent | Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stadterman, MPH, CCRP | UPMC Hillman Cancer Center | 4126475554 | stadtermanbm@upmc.edu |
Not provided
| 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 | May 22, 2019 | Apr 1, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
|
| Cisplatin | Drug | Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. |
|
|
| IMRT | Radiation | IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
|
The number of patients who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
| Up to 6 months |
| 1-year Locoregional Failure Rate | Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 1 year. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site. | Up to 1 year |
| 3-year Locoregional Failure Rate | Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 3 years. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site. | Up to 3 years |
| Overall Survival (OS) | The length of time from start of study treatment that patients are still alive. | Up to 48 months |
| Overall Survival (OS) at ≤ 12 Months | Probability of patients (expressed as a percentage) still alive at less than or equal to 12 months after start of study. | Up to12 months |
| Overall Survival (OS) at ≤ 36 Months | Probability of patients (expressed as a percentage) still alive at less than or equal to 36 months after start of study. | Up to 36 months |
| Overall Survival (OS) at ≤ 48 Months | Probability of patients (expressed as a percentage) still alive at less than or equal to 48 months after start of study. | Up to 48 months |
| Derived |
| Ferris RL, Moskovitz J, Kunning S, Ruffin AT, Reeder C, Ohr J, Gooding WE, Kim S, Karlovits BJ, Vignali DAA, Duvvuri U, Johnson JT, Petro D, Heron DE, Clump DA, Bruno TC, Bauman JE. Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1335-1344. doi: 10.1158/1078-0432.CCR-21-0426. |
| BG001 | Cisplatin + Radiation + Pembrolizumab - Sequential | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation. Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ECOG | Eastern Cooperative Oncology Group (ECOG) performance status (Score 0 - 4): 0 Fully active; no performance restrictions.
| Count of Participants | Participants |
|
| Stage | NATIONAL CANCER INSTITUTE STAGING Stage 0 = Abnormal cells are present but have not spread to nearby tissue. Also called carcinoma in situ, or CIS. CIS is not cancer, but it may become cancer. Stage I, Stage II, and Stage III = Cancer is present. NOTE - The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV = The cancer has spread to distant parts of the body. Higher stages indicate greater disease burden. | Count of Participants | Participants |
|
| T Stage | NATIONAL CANCER INSTITUTE STAGING - The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor. Primary tumor (T) TX: Main tumor cannot be measured. T0: Main tumor cannot be found. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. | Count of Participants | Participants |
|
| N Stage | NATIONAL CANCER INSTITUTE TNM Staging System Regional lymph nodes (N) The N refers to the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. Higher numbers indicate greater disease burden. | Count of Participants | Participants |
|
| Histology | Classification of tissues and cells under a microscope. | Count of Participants | Participants |
|
| Primary Site | Count of Participants | Participants |
|
| p16 for oropharynx | Patient status for presence of Human papillomavirus (HPV) strain p16 | Count of Participants | Participants |
|
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
| OG001 | Cisplatin + Radiation + Pembrolizumab - Sequential | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation. Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. |
|
|
| Primary | Progression-free Survival at ≤ 36 Months | Probability of participants (expressed as a percentage) without disease progression at less than or equal to 36 months after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | All patients that received treatment and were radiologically evaluable for response. | Posted | Number | percentage of patients | Up to 36 months |
|
|
|
| Primary | Progression-free Survival at ≤ 48 Months | Probability of participants (expressed as a percentage) without disease progression time from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1: Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | All patients that received treatment and were radiologically evaluable for response. | Posted | Number | percentage of patients | Up to 48 months |
|
|
|
| Primary | Acute Toxicity / DLT Rate | The number of patients who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0 | All treated patients. | Posted | Count of Participants | Participants | Up to 6 months |
|
|
|
| Primary | 1-year Locoregional Failure Rate | Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 1 year. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site. | All treated patients. | Posted | Number | percent probability of participants | Up to 1 year |
|
|
|
| Primary | 3-year Locoregional Failure Rate | Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 3 years. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site. | All treated patients. | Posted | Number | percent probability of participants | Up to 3 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | Median number of months from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1 Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | All patients that received treatment and were radiologically evaluable for response. | Posted | Median | 95% Confidence Interval | months | Up to 48 months |
|
|
|
| Secondary | Overall Survival (OS) | The length of time from start of study treatment that patients are still alive. | All patients on study. | Posted | Median | 95% Confidence Interval | months | Up to 48 months |
|
|
|
| Secondary | Overall Survival (OS) at ≤ 12 Months | Probability of patients (expressed as a percentage) still alive at less than or equal to 12 months after start of study. | All patients on study. | Posted | Number | percentage of patients | Up to12 months |
|
|
|
| Secondary | Overall Survival (OS) at ≤ 36 Months | Probability of patients (expressed as a percentage) still alive at less than or equal to 36 months after start of study. | All patients on study. | Posted | Number | percentage of patients | Up to 36 months |
|
|
|
| Secondary | Overall Survival (OS) at ≤ 48 Months | Probability of patients (expressed as a percentage) still alive at less than or equal to 48 months after start of study. | All patients on study. | Posted | Number | percentage of patients | Up to 48 months |
|
|
|
| 11 |
| 41 |
| 21 |
| 41 |
| 38 |
| 41 |
| EG001 | Cisplatin + Radiation + Pembrolizumab - Sequential | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation. Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. | 6 | 39 | 10 | 39 | 38 | 39 |
| Blood and lymphatic system disorders - Other, specifythrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifyHypertension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colonic obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Duodenal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyDizziness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyBacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyLung Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifySepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifypenumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifypneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifypneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyCellulitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specifyGJ Tube revision | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specifygranulomatous lymphadenitis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specifyvenous thrombosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aortic valve disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifyBradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifyCAD | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifyCoronary artery calcifications | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifyMild aortic insufficiency | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifyMurmur | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifySVC (left) | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifychronic obstructive pulmonary disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specifycoronary artery disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mitral valve disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specifyEar Pressure | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specifyHearing Loss | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specifyItching Ears | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specifyOtotoxicity | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specifyRight Otalgia | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Endocrine disorders - Other, specifyDiabetes | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Endocrine disorders - Other, specifyTSH increased | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyDry Heaves | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyFracture Tooth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyGagging | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyGum Soreness | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyOdyNphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyOral cavity erythema | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyOropharvngeal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyPain - swallowing | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifyodyNphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specifypNumatosis intestinalis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Salivary duct inflammation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tooth development disorder | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Facial pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyBenign prostatic hyperplasia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyErythema of throat | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyExcess phlegm | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intermittent ear pain left side jaw/oral | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyPain in right neck/oral | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyThroat pain with swallowing | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyallergies seasonal | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyintermittent L thigh pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| intermittent ear, jaw left side pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyneuropathic pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifyodyNphagia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifythroat pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specifytumor bleeding | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Immune system disorders - Other, specifydecreased lymphocytes | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Immune system disorders - Other, specifyseasonal allergies | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyIncreased LDH | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyOral Thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyOral thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyRash-forearm itching | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyShingles | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyThrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyaspiration pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifyinfusion related reaction | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specifythrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Phlebitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specifyInfusion Reaction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Intraoperative neurological injury | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyANC Decrease | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyAlanine AmiNtransferase decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyBPH destruction | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyBUN elevation | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyBUN increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyBlisters | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyCreatine Clearance Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyElevated BUN | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyIncreased Thyroid Peroxidase Antibodies | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyLDH Increase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyLDH increase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyLDH increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyLow testosterone | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyLyme Disease | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyRadionecrosis - Mouth | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyTSH increase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyThrush | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyThyroid Peroxodase Ab | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyVitamin D deficiency | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyelevated TSH | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyfacial infection | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyhyperhydrosis | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyhyperlipidemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyoral thrush | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifyradionecrosis | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifysoft tissue nuerosis | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specifythyroid peroxidase antibodies | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specifyCachexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specifyDiabetes Type II | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specifyHYPERLIPIDEMIA | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specifyHypercholesterolemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specifyhypercholesterolemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyBilateral Upper Limb Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyCervical spondylosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyHeavy feet/stiffness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyIntermittent left thigh pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyJaw Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyOA | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyParesthesia (Hands/ R Leg) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyRadiation Fibrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyRib pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyRight Leg Pain Sciatica | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyRight Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyRight neck stiffness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifySpinal SteNsis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specifyThroat Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyAdrenal AdeNma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Aphonia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Movements involuntary | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifyAutoNmic Insufficiency | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifyNeuropathic pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifyOdyNphagia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifyPresyncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifySPINAL STENSIS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifydysosmia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specifynumb right ear | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Prostatic obstruction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specifyBenign Prostatic Hyperplasia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specifyBenign prostatic hypertrophy | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifyCOPD | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifyEmphysema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifyThroat erythema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifyUlceration oropharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifyUpper Respiratoty Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifylung Ndules | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specifysob with exertion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify65cm open area Rt neck | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyBruising periorbital | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyDermatitis of right lower extremity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyErythema Throat | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyNeck wound | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyPuritic skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyTape Burn to abd area | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specifyrash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specifyinfusion siite extravastion | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specifytracheostomy site bleeding | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specifytumor bleeding | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Superficial thrombophlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular disorders - Other, specifyCoronary artery disease | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular disorders - Other, specifyLeft Ventricle Hypertrophy | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular disorders - Other, specifyVascular access complication | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vasculitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |