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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00002507
First received: November 1, 1999
Last updated: July 24, 2013
Last verified: June 2000

November 1, 1999
July 24, 2013
November 1992
October 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002507 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Primary Purpose: Treatment
  • Carcinoma of Unknown Primary
  • Head and Neck Cancer
  • Drug: mitomycin C
  • Drug: porfiromycin
  • Radiation: brachytherapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2002
October 2002   (final data collection date for primary outcome measure)

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

Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002507
CDR0000078021, YALE-HIC-6611, NCI-V92-0190
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Yale University
Yale University
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Study Chair: James J. Fischer, MD, PhD Yale University
Yale University
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP