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Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) University of Pittsburgh |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004659 |
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 | Intervention | Phase |
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Brain Neoplasms |
Procedure: irradiation Procedure: radiosurgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 40 |
Study Start Date: | November 1994 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 199/11858, UPPUH-9511117 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004659 |
Health Authority: | United States: Federal Government |
adult brain tumor brain tumor childhood brain tumor genetic condition |
nervous tissue tumors oncologic disorders rare disease |
Brain Neoplasms Rare Diseases Central Nervous System Diseases |
Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases |