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Phase III Randomized Study of Radiotherapy vs Radiotherapy plus Metronidazole as Radiosensitization in Patients with Advanced Gynecologic Malignancies

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

no age specified

NCI

MSKCC-8082
NCI-T83-1374D, T83-1374

Objectives

I.  Evaluate the effectiveness of metronidazole (flagyl) as a radiosensitizer 
in patients with advanced gynecologic tumors.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with a histologically 
confirmed diagnosis of Stage III/IV endometrial, vulvar, and vaginal cancer 
and Stage IIIB/IV cervical cancer.  There may be surgical recurrence.  There 
may have been no prior chemotherapy or radiotherapy.  A history of ulcerative 
colitis excludes.

Expected Enrollment

60 patients will be accrued per arm (120 total); 40 patients will be accrued 
per year for 3 years.

Outline

Randomized study.
Arm I:  Radiosensitization plus Radiotherapy.  Metronidazole, Flagyl, 
NSC-69587; plus pelvic irradiation with 10 or 18 MeV photons.
Arm II:  Radiotherapy.  As in Arm I.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dattatreyudu Nori, MD, Protocol chair
Ph: 212-746-3679
Email: dnori@nyp.org

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.