Status:
COMPLETED
Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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. ...
Detailed Description
OBJECTIVES: Primary * To compare the progression-free survival (PFS) of patients with locally advanced squamous cell carcinoma of the head and neck treated with standard fractionation radiotherapy a...
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
Exclusion
Key Trial Info
Start Date :
December 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2017
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00820248
Start Date
December 30 2008
End Date
February 17 2017
Last Update
August 22 2023
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
2
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
3
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
4
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9