Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced, Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- UNICANCER
- Enrollment
- 160
- Locations
- 11
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.
Detailed Description
OBJECTIVES: * Compare the overall survival and survival without relapse for 1, 3, and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil. * Compare the presence of distant metastases at 1, 3, and 5 years in these patients after these treatments. * Compare the local control and duration of control in these patients after these treatments. * Compare the clinical changes and histological changes at 6 months in these patients after these treatments. * Determine the rate of complete response in these patients after these treatments. * Determine the early and late toxic effects of these regimens in these patients. * Determine the quality of life of these patients. * Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and primary site of disease (oropharynx vs hypopharynx) Patients are randomized to one of two treatment arms. * Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7 weeks. * Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5. Courses are repeated every 3 weeks for 3 courses. Patients are followed every month for 1 year, every 2-3 months for 2 years, then every 6 months for at least 2 years. PROJECTED ACCRUAL: A total of 160 patients (80/arm) will be accrued for this study within 4.5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified