Overview

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

Status:
Completed
Trial end date:
2005-09-01
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNICANCER
Treatments:
Fluorouracil
Criteria
DISEASE CHARACTERISTICS: Histologically proven stage I-IVB squamous cell cancer of the oral
cavity, oropharynx, hypopharynx, or larynx Positive lymph nodes allowed, either bilateral
or contralateral Curatively resected within past 6 weeks No distant metastases

PATIENT CHARACTERISTICS: Age: Over 18 to 70 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 2,000/mm3 Platelet count at least
150,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and
SGPT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No
contraindication to fluorouracil IV No coronary artery disease greater than grade 2 No
unstable heart disease Other: No other malignancy except basal cell skin cancer or
carcinoma in situ of the cervix Not pregnant 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 Surgery:
See Disease Characteristics Other: No other concurrent adjuvant therapy No concurrent
preventive treatment (e.g., retinoids) No other concurrent experimental treatment