500 Boylston Street, Boston, MA 02116 617-419-4700
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RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving
radiation therapy in different ways and combining it with chemotherapy before surgery may
kill more tumor cells. It is not yet known which radiation therapy regimen combined with
chemotherapy with or without surgery is more effective for head and neck cancer.
PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens
combined with cisplatin with or without surgery in treating patients who have stage III or
stage IV head and neck cancer.
Active, not recruiting
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx - Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0) - No metastases below the clavicle or more distant by clinical exam or radiology PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 50 mL/min - Calcium normal Cardiovascular - No symptomatic coronary artery disease (angina) - No myocardial infarction within the past 6 months Other - No other invasive malignancy within the past 3 years except nonmelanoma skin cancer - No simultaneous primary tumors - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the head and neck except radioactive iodine therapy Surgery - No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease - No radical or modified neck dissection
Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00047008
Not Accepting Healthy Volunteers