NCT00002507

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

RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: I. Compare the efficacy of mitomycin vs. porfiromycin as an adjunct to radiotherapy for the treatment of epidermoid carcinomas of the head and neck. OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Irradiation of involved head and neck sites by external-beam radiotherapy (EBRT) alone (source not specified), brachytherapy alone (using permanent or removable radiation sources), or both; plus Mitomycin, MITO, NSC-26980. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Radiotherapy as in Arm I; plus Porfiromycin, NSC-56410. PROJECTED ACCRUAL: Approximately 200 patients will be entered over 3-4 years.

Conditions

• Carcinoma of Unknown Primary
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	mitomycin C
DRUG	porfiromycin
RADIATION	brachytherapy
RADIATION	radiation therapy

Timeline

• Start date: 1992-11-01
• Primary completion: 2002-10-01
• Completion: 2002-10-01
• First posted: 2004-08-10
• Last updated: 2013-07-25

Locations

1 site across 1 country: United States