Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
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.
|Metastatic Cancer||Procedure: surgical procedure Radiation: radiation therapy Radiation: stereotactic radiosurgery||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES|
|Study Start Date:||January 1996|
|Study Completion Date:||December 2004|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Whole brain radiation therapy (WBRT) to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week followed by radiosurgery to all metastases
|Procedure: surgical procedure Radiation: radiation therapy Radiation: stereotactic radiosurgery|
Active Comparator: Arm 2
WBRT to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week
|Radiation: radiation therapy|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002708
Show 258 Study Locations
|Study Chair:||David W. Andrews, MD, FACS||Sidney Kimmel Cancer Center at Thomas Jefferson University|