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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-HN6 | Registry Identifier | NCI US - Physician Data Query | |
| CDR0000630159 | Other Identifier | PDQ |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer.
PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to T category (T1-3 vs T4), nodal status (N0-1 vs N2 vs N3), radiotherapy delivery modality (intensity-modulated [IMRT] vs 3-D conformal [3D CRT]), anatomic location (hypopharynx vs oral cavity vs oropharynx vs larynx), and participation in the optional swallowing impairment substudy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life (QOL) (FACT-H&N), swallowing-related QOL (MDADI, SWAL-QOL), swallowing function (FOIS), and economic evaluations (Lost Productivity questionnaire) are assessed periodically during the study.
After completion of study treatment, patients are followed periodically for at least 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. |
|
| Arm II | Experimental | Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab | Biological | Given IV |
| |
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Rate | The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported. | 6.2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate | Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported. | 6.2 years |
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DISEASE CHARACTERISTICS:
Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
Locally advanced disease, defined by any of the following criteria:
No current history of unknown primary squamous cell carcinoma of the head and neck, primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neck
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Absolute granulocyte count ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST or ALT ≤ 3 times ULN
Creatinine clearance > 50 mL/min
Magnesium > 0.5 mmol/L
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Must be accessible for treatment and follow-up
Able (sufficiently fluent) and willing to complete the quality of life (QOL) and swallowing QOL questionnaires in either English or French
Must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation
No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors
No history of allergic or hypersensitivity reactions to any of the study drugs or their excipients
No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) on baseline CT scan
No peripheral neuropathy ≥ grade 2 (CTCAE v3.0)
No hearing loss/tinnitus ≥ grade 3 (CTCAE v3.0)
No thromboembolic event within the past 12 months despite being treated with anticoagulation drugs
None of the following allowed:
PRIOR CONCURRENT THERAPY:
No prior surgical treatment except diagnostic biopsy for this disease
No prior induction chemotherapy for this disease
No prior radiation to the head and neck region that would result in overlap of fields for this study
No prior cisplatin or carboplatin chemotherapy
No prior targeted anti-EGFR therapy of any kind
At least 30 days since any prior investigational agent
No concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy
No concurrent erythropoietic growth factors, pilocarpine, amifostine, other anticancer therapy (e.g., cytotoxic agents, biological response modifiers, immunotherapy, or hormonal therapy), or other investigational drug therapy
The following radiological investigations must be done within 8 weeks of randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada | Principal Investigator |
| John Waldron, MD | Princess Margaret Hospital, Canada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada | ||
| BCCA - Fraser Valley Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28040660 | Background | Ringash J, Waldron JN, Siu LL, Martino R, Winquist E, Wright JR, Nabid A, Hay JH, Hammond A, Sultanem K, Hotte S, Leong C, El-Gayed AA, Naz F, Ramchandar K, Owen TE, Montenegro A, O'Sullivan B, Chen BE, Parulekar WR. Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6). Eur J Cancer. 2017 Feb;72:192-199. doi: 10.1016/j.ejca.2016.11.008. Epub 2016 Dec 29. | |
| 27930762 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin | Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Given IV |
|
| 3-dimensional conformal radiation therapy | Radiation | Patients undergo radiotherapy |
|
| accelerated radiation therapy | Radiation | Patients undergo accelerated fractionation radiotherapy |
|
| intensity-modulated radiation therapy | Radiation | Patients undergo radiotherapy |
|
| Surrey |
| British Columbia |
| V3V 1Z2 |
| Canada |
| BCCA - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Atlantic Health Sciences Corporation | Saint John | New Brunswick | E2L 4L2 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | AIB 3V6 | Canada |
| Northeast Cancer Center Health Sciences | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Ottawa Health Research Institute - General Division | Ottawa | Ontario | K1H 8L6 | Canada |
| Thunder Bay Regional Health Science Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Univ. Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| McGill University - Dept. Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| CHUQ-Pavillon Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Result |
| Siu LL, Waldron JN, Chen BE, Winquist E, Wright JR, Nabid A, Hay JH, Ringash J, Liu G, Johnson A, Shenouda G, Chasen M, Pearce A, Butler JB, Breen S, Chen EX, FitzGerald TJ, Childs TJ, Montenegro A, O'Sullivan B, Parulekar WR. Effect of Standard Radiotherapy With Cisplatin vs Accelerated Radiotherapy With Panitumumab in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):220-226. doi: 10.1001/jamaoncol.2016.4510. |
| 25633805 | Derived | Cuffe S, Hon H, Tobros K, Espin-Garcia O, Brhane Y, Harland L, Fadhel E, Eng L, LaDelfa A, Waldron J, Siu LL, Chen BE, Xu W, Simmons C, Kassam Z, Montenegro A, Parulekar WR, Liu G. Cancer patients' acceptability of incorporating an epidemiology questionnaire within a clinical trial. Clin Trials. 2015 Jun;12(3):237-45. doi: 10.1177/1740774514568689. Epub 2015 Jan 29. |
| FG001 |
| Panitumumab |
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy |
| Received Protocol Treatment | Only treated patients were evaluated for adverse event. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin | Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy |
| BG001 | Panitumumab | Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | Performance Status: 0: Fully active, able to carry on all pre-disease performance without restriction 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work | Count of Participants | Participants |
| |||||||||||||||
| Anatomic Location | Count of Participants | Participants |
| ||||||||||||||||
| Smoking | Count of Participants | Participants |
|
| 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 (PFS) Rate | The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported. | Posted | Count of Participants | Participants | 6.2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate | Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported. | Posted | Count of Participants | Participants | 6.2 years |
|
|
6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin | Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy | 43 | 160 | 0 | 156 | 156 | 156 |
| EG001 | Panitumumab | Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy | 32 | 160 | 0 | 159 | 159 | 159 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing (monitoring program) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing (without monitoring program) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain External ear | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Middle ear | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chelitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis (clinical exam) Oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis (functional/symptomatic) Oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Abdomen NOS | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Salivary gland changes | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Teeth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema: head and neck | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection with normal ANC Catheter-related | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis Chemoradiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | 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 |
| |
| Fibrosis-deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Bone | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Joint | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Neck | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy-motor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Head/headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Taste alteration | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mood alteration Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mood alteration Depression | Psychiatric 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 |
| |
| Edema, larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis (clinical exam) Pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatology - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hand-foot | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Parulekar | Canadian Cancer Trials Group | 613-533-6430 | wparulekar@ctg.queensu.ca |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D002945 | Cisplatin |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| Oropharynx |
|
| Larynx |
|
| Hypopharynx |
|
| Yes |
|
| Counts |
|---|
| Participants |
|
|
|