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
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|ClinicalTrials.gov Identifier: NCT00004659|
Recruitment Status : Unknown
Verified March 1999 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms||Procedure: irradiation Procedure: radiosurgery||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Study Start Date :||November 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004659
|Study Chair:||Douglas Kondziolka||University of Pittsburgh|