RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA
20 Years
80 Years
Both
Carcinoma of Unknown Primary, Head and Neck Cancer
Trial Information
RADIATION WITH MITOMYCIN C OR PORFIROMYCIN IN THE TREATMENT OF CANCER OF THE HEAD AND NECK AREA
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
James J. Fischer, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000078021
NCT ID:
NCT00002507
Start Date:
November 1992
Completion Date:
Related Keywords:
- Carcinoma of Unknown Primary
- Head and Neck Cancer
- stage I squamous cell carcinoma of the lip and oral cavity
- stage I adenoid cystic carcinoma of the oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage II adenoid cystic carcinoma of the oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent adenoid cystic carcinoma of the oral cavity
- stage I squamous cell carcinoma of the oropharynx
- stage I lymphoepithelioma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent lymphoepithelioma of the oropharynx
- stage I squamous cell carcinoma of the nasopharynx
- stage I lymphoepithelioma of the nasopharynx
- stage II squamous cell carcinoma of the nasopharynx
- stage II lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent lymphoepithelioma of the nasopharynx
- stage I squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- newly diagnosed carcinoma of unknown primary
- recurrent carcinoma of unknown primary
- Carcinoma
- Head and Neck Neoplasms
- Neoplasms, Unknown Primary
Name | Location |
|---|---|
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
