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
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Volunteers
Inclusion and exclusion criteria
- Multiple newly diagnosed brain tumors
- Histologic confirmation of carcinoma at primary or metastatic site
- Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm
- No more than 4 tumors on magnetic resonance imaging
- Systemic disease controlled
- Neurologic function preserved
- Radiographic staging within 2 months of randomization required
- Performance status: Karnofsky 70%-100%
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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