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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Treatment Completed no age specified NCI SWOG-7811

Objectives

I.  Determine the effectiveness of combined radiation therapy and flagyl in 
the treatment of patients with brain metastases from primary malignancies 
outside the central nervous system, compared with radiation therapy alone, as 
determined by objective response (brain and/or CAT scan) and/or increase in 
functional neurologic level and duration of response.
II.  Determine the toxicity of multiple dose administration of flagyl and 
radiation therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
primary malignancy with suspected brain metastases measurable by brain scan, 
CAT scan or neurologic status level 2 through 4.  Patients must have a minimum 
expected life span of 1 month and may not have had prior radiotherapy to the 
brain.  Patients may not have concurrent chemotherapy with agents known to 
pass the blood-brain barrier, and must have been removed from such therapy for 
specified time, unless they failed an adequate trial with any of these agents.

Expected Enrollment

152 patients will be entered within 2 years.  Protocol closed May 1982.

Outline

Randomized study.  Enter all patients to Regimen A; randomize patients to Arm 
I or II.
Regimen A:  Single-agent Hormone Therapy.  Dexamethasone, DM, NSC-34521.
Arm I:  Radiosensitization plus Radiotherapy.  Flagyl, Metronidazole, 
NSC-69587; plus Radiotherapy, Co-60 or megavoltage.
Arm II:  Radiotherapy.  Co-60 or megavoltage.

Eyre HJ, Ohlsen JD, Frank J, et al.: Randomized trial of radiotherapy versus radiotherapy plus metronidazole for the treatment metastatic cancer to brain. A Southwest Oncology Group study. J Neurooncol 2 (4): 325-30, 1984.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair(Contact information may not be current)		Ph: 210-567-2710