Completed

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

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What is being tested

mitomycin C

+ porfiromycin

+ brachytherapy

DrugRadiation
Who is being recruted

Carcinoma+10

+ Carcinoma, Squamous Cell

+ Neoplasm Metastasis

From 20 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 1992
See protocol details

Summary

Principal SponsorYale University
Last updated: July 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00002507
Principal SponsorYale University
Last updated: July 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Squamous CellNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsSquamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsNeoplasms, Unknown Primary

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Yale Comprehensive Cancer Center

New Haven, United StatesOpen Yale Comprehensive Cancer Center in Google Maps
CompletedOne Study Center