Overview
Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer
Status:
Completed
Completed
Trial end date:
2002-10-01
2002-10-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Yale UniversityTreatments:
Mitomycin
Mitomycins
Porfiromycin
Criteria
DISEASE CHARACTERISTICS: Biopsy-proven epidermoid carcinoma of the following head and necksites: 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