Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases

Metastatic Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

• NCT number: NCT00002708
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 3
• Start date: January 1996
• Completion date: December 2004