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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002507
• Other study ID #: CDR0000078021
• Secondary ID: YALE-HIC-6611NCI
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 24, 2013
• Start date: November 1992
• Est. completion date: October 2002

Study information

• Verified date: June 2000
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of Unknown Primary
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplasms, Unknown Primary

Intervention

Drug:
• mitomycin C

• porfiromycin

Radiation:
• brachytherapy

• radiation therapy

Locations

Country	Name	City	State
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States,