Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 20 to 80 Other YALE-HIC-6611 NCI-V92-0190, NCT00002507

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.

Entry 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

Prior/Concurrent Therapy:

At least 3 years since chemotherapy
No prior radiotherapy to areas of current disease

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

Expected Enrollment

Approximately 200 patients will be entered over 3-4 years.

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.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

James Fischer, MD, PhD, Protocol chair		Ph: 203-785-2956; 866-925-3226

Registry Information
Official Title		RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA
Trial Start Date		1992-11-25
Registered in ClinicalTrials.gov		NCT00002507
Date Submitted to PDQ		1992-11-25
Information Last Verified		2000-06-01