Overview

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

Status:
Completed
Trial end date:
2002-10-01
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 combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Treatments:
Mitomycin
Mitomycins
Porfiromycin
Criteria
DISEASE CHARACTERISTICS: Biopsy-proven epidermoid carcinoma of the following head and neck
sites: Hypopharynx Oral cavity Larynx Oropharynx Nasopharynx Unknown primary origin with
positive head and neck nodes TNM Stages I-IV or recurrent disease with no distant
metastases, i.e.: T1 N0 M0 T1 N1-3 M0 T2-4 any N M0 T0 N1-3 M0 No carcinoma of the true
vocal cord or other condition with greater than 90% probability of cure

PATIENT CHARACTERISTICS: Age: 20 to 80 Performance status: Not specified Hematopoietic: WBC
at least 3,000 Platelets at least 100,000 Hct at least 25% Hepatic: Bilirubin less than 1.5
mg/dl Renal: Creatinine less than 2 mg/dl OR BUN less than 40 mg/dl Other: No other
serious, life-threatening illness No second malignancy within 5 years except
nonmelanomatous skin cancer outside the planned radiotherapy field

PRIOR CONCURRENT THERAPY: At least 3 years since chemotherapy No prior radiotherapy to
areas of current disease