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


Phase 3
20 Years
80 Years
Not Enrolling
Both
Carcinoma of Unknown Primary, Head and Neck Cancer

Thank you

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