Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients who have stage III or stage IV head and neck cancer.
Head and Neck Cancer
Drug: chemosensitization/potentiation therapy
Radiation: low-LET photon therapy
Radiation: radioisotope therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||RANDOMIZED PHASE II TRIAL OF TIRAPAZAMINE AND THE ROLE OF TUMOR HYPOXIA IN ADVANCED SQUAMOUS HEAD AND NECK CANCER|
|Study Start Date:||June 1996|
OBJECTIVES: I. Compare the complete response rate following radiotherapy with or without tirapazamine (SR-4233) in patients with N1 squamous cell carcinoma of the head and neck. II. Compare the complete response rate to induction chemotherapy with cisplatin (CDDP) and fluorouracil (5-FU) with and without SR-4233 followed by concurrent CDDP/5-FU plus radiotherapy with and without SR-4233 in patients with N2 or N3 squamous cell carcinoma of the head and neck. III. Assess whether tumor hypoxia contributes to tumor resistance to treatment by measuring oxygen tension in cervical lymph node metastases and correlating these results with treatment response in both groups of patients.
OUTLINE: This is a randomized study. Patients are stratified according to pO2 values (high vs low). Patients are randomized to one of two treatment arms. Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV continuously on days 1-5 and cisplatin IV over 4 hours on day 1. Treatment is repeated every 21 days for 2 courses. Patients who achieve at least partial response proceed to chemoradiotherapy consisting of cisplatin IV over 30-60 minutes, three times a week, during weeks 1 and 5. Patients also receive fluorouracil IV continuously for 4 days beginning on day 43 and again on day 71. Radiotherapy begins on day 43 (week 1) for 5.5 weeks. Patients with no response or progressive disease after induction chemotherapy proceed to salvage surgery. Arm II: Patients receive induction chemotherapy as in arm I plus tirapazamine IV over 1.0-2.5 hours prior to cisplatin. Patients proceed as in arm I. Those patients receiving chemoradiotherapy also receive tirapazamine IV on the same days as cisplatin. Some patients receive further radiotherapy and/or surgery. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over approximately 5 years.
|United States, California|
|Veterans Affairs Medical Center - Palo Alto|
|Palo Alto, California, United States, 94304|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|Study Chair:||Harlan A. Pinto, MD||Stanford University|