Overview

Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
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. It is not yet known whether surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Centre, Singapore
Treatments:
Fluorouracil
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed head and neck squamous cell cancer (excluding nasopharynx and
salivary glands) on biopsy of the primary lesion or the neck mass

- Stage III or IV disease

- No evidence of distant or systemic metastases

- Resectable disease

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- SGOT less than 2 times upper limit of normal

- Bilirubin less than 1.4 mg/dL

Renal:

- Creatinine less than 1.6 mg/dL

Other:

- No prior or concurrent primary malignancies

- 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 to the head and neck

Surgery:

- See Disease Characteristics

- No prior surgery (other than biopsy)