Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy Vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors

National Institute of Neurological Disorders and Stroke (NINDS)0 sites40 target enrollmentNovember 1994

ConditionsBrain Neoplasms

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Brain Neoplasms
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Enrollment: 40
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function.

II. Examine survival, clinical outcome, and local tumor imaging response in these patients.

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment. The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first. Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

Registry

clinicaltrials.gov

Start Date

November 1994

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All