Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
- Conditions
- Metastatic Cancer
- Registration Number
- NCT00002708
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery.
- Detailed Description
OBJECTIVES: I. Compare the overall survival of patients with one unresected brain metastasis treated with conventional whole brain radiotherapy (WBRT) with vs. without a stereotactic radiosurgery (SRS) boost. II. Compare sites of recurrence and cause of death in these patients treated with WBRT followed by SRS vs. WBRT alone.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and extracranial disease (yes or no). Patients are randomized to one of two treatment arms. Arm I: Patients receive fractionated external beam whole brain irradiation (WBRT) 5 days each week for 3 weeks. Both portals are treated during each radiotherapy session. Patients who still have a solitary lesion with a diameter no greater than 4.0 cm also receive stereotactic radiosurgery within 7 days of completing WBRT. Arm II: Patients receive WBRT only. Patients are followed every 3 months for 1 year, then every 4 months for 2 years, and then annually.
PROJECTED ACCRUAL: A total of 262 patients will be accrued over 2.5-3.75 years for this study. The study may close early if interim analysis after 33% and 67% of patients have been followed for 6 months produces significant results. After 6/14/99 an additional 46 patients with a solitary brain metastasis only will be accrued.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (258)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Urology Associates - Mobile AL
🇺🇸Mobile, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscallosa, Alabama, United States
Providence Cancer Therapy Center
🇺🇸Anchorage, Alaska, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
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