Overview

High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer

Status:
Completed
Trial end date:
1969-12-31
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 head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
Cobalt
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and
neck of the following sites: Oral cavity Oropharynx Hypopharynx (only if ineligible for
protocol EORTC-24891) Larynx T3-4, any N, M0 or any T, N2-3, M0 disease (UICC staging)
resected with curative intent T3, N0 carcinoma of the larynx with suitable microscopically
clear margins is ineligible At least one of the following high-risk characteristics
required: Histopathologically positive surgical margins No gross residual disease
Perineural involvement Extranodal spread of disease Oral cavity or oropharyngeal lesions
with metastatic nodes at level 4 or 5 Vascular embolisms in the neck No metastases at
diagnosis No known CNS disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at
least 4,000 Platelets at least 100,000 Hemoglobin normal (at least 6.8 mmoles/liter)
Hepatic: Bilirubin no greater than 2 times normal Other liver function tests no greater
than 2 times normal Renal: Creatinine no greater than 1.3 mg/dL (120 micromoles/liter)
Creatinine clearance greater than 60 mL/min Other: No active, uncontrolled infection No
requirement for antibiotics that might interfere with platinum excretion No requirement for
drugs affecting bone marrow function (e.g., lithium, corticosteroids) No medical condition
precluding postoperative chemotherapy No prior or concurrent malignancy other than
nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior locoregional
radiotherapy to the head and neck Surgery: Excision with curative intent required