Phase
Condition
Nasopharyngeal Cancer
Human Papilloma Virus (Hpv)
Head And Neck Cancer
Treatment
intensity-modulated radiation therapy
3-dimensional conformal radiation therapy
panitumumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
Any T, N+, M0
T3-4, N0, M0
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
Prior thromboembolic event > 12 months allowed provided patient is stable on anticoagulation or on preventative anticoagulation
None of the following allowed:
Myocardial infarction within the past 12 months
Uncontrolled severe congestive heart failure
Unstable angina
Active cardiomyopathy
Unstable ventricular arrhythmia
Uncontrolled hypertension
Uncontrolled psychiatric disorder
Active serious infection
Active peptic ulcer disease
Any other medical condition that might interfere with protocol therapy delivery
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:
MRI or CT of the head and neck
CT chest
Study Design
Study Description
Connect with a study center
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia V3V 1Z2
CanadaSite Not Available
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
Atlantic Health Sciences Corporation
Saint John, New Brunswick E2L 4L2
CanadaSite Not Available
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador AIB 3V6
CanadaSite Not Available
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario K7L 5P9
CanadaSite Not Available
London Regional Cancer Program
London, Ontario N6A 4L6
CanadaSite Not Available
Ottawa Health Research Institute - General Division
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Northeast Cancer Center Health Sciences
Sudbury, Ontario P3E 5J1
CanadaSite Not Available
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario P7B 6V4
CanadaSite Not Available
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Hopital Maisonneuve-Rosemont
Montreal, Quebec H1T 2M4
CanadaSite Not Available
McGill University - Dept. Oncology
Montreal, Quebec H2W 1S6
CanadaSite Not Available
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec G1R 2J6
CanadaSite Not Available
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
CanadaSite Not Available
Saskatoon Cancer Centre
Saskatoon, Saskatchewan S7N 4H4
CanadaSite Not Available
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