Overview

Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Head and Neck Cancer

Status:
Completed

Trial end date:
2000-07-01

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 if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with advanced head and neck cancer.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Swiss Group for Clinical Cancer Research

Treatments:

Cisplatin
Cobalt

Criteria

DISEASE CHARACTERISTICS: Histologically documented squamous cell cancer of the head and
neck in the following sites: Hypopharynx Larynx Oral cavity Oropharynx Stage III/IV disease
No distant metastases by the following: Chest x-ray (all patients) Liver ultrasound or CT
and bone scintigraphy (all hypopharyngeal cancers, those with involved lower neck nodes,
and as clinically indicated) Multiple sites of disease eligible provided radiotherapy
treatment volume remains acceptable

PATIENT CHARACTERISTICS: Age: 20 to 75 Performance status: WHO 0-2 Hematopoietic: WBC
greater than 3,000 Platelets greater than 100,000 Hepatic: Not specified Renal: Creatinine
clearance at least 60 ml/min No renal disease or impairment of renal function
Cardiovascular: No coronary heart disease No cardiac failure No history of pulmonary
embolism within 2 years Other: No clinical hearing impairment No peripheral neuropathy with
concomitant handicap No severe diabetes mellitus with serious vasculopathy or neuropathy No
second cancer except: Nonmelanomatous skin or lip cancer In situ carcinoma of the cervix
Blood/body fluid analyses to determine eligibility completed within 14 days prior to
registration

PRIOR CONCURRENT THERAPY: No prior treatment for head and neck cancer Excisional biopsy for
diagnosis allowed