Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma of Unknown Primary; Head and Neck Cancer
Intervention: mitomycin C (Drug); porfiromycin (Drug); brachytherapy (Radiation); radiation therapy (Radiation)
Phase: Phase 3
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): James J. Fischer, MD, PhD, Study Chair, Affiliation: Yale University
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.
Clinical Details
Official title: RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA
Study design: Primary Purpose: Treatment
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Yale Comprehensive Cancer Center, New Haven, Connecticut 06520-8028, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 1992
Last updated: July 24, 2013
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