Surgery and Radiation Therapy With or Without Chemotherapy in Treating Patients With Mouth Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage II, stage III, or stage IV mouth cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Cobalt; Fluorouracil

Criteria

DISEASE CHARACTERISTICS: Squamous cell carcinoma of the lower oral cavity eligible for resection T2 (greater than 3 cm), T3, or T4, and N0-3 M0 (UICC staging system) No requirement for postsurgical reconstruction that would impede further radiotherapy

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: WHO 0 or 1 Hematopoietic:

WBC at least 3,500/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 110,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 50 mg/mL BUN no greater than 50 mg/dL Cardiovascular: No cardiopathy Other: No significant internal disease No prior malignancy except basal cell carcinoma of the skin No geographic barrier to treatment

PRIOR CONCURRENT THERAPY: No prior therapy