Prospective Randomized Trial Between WBRT Plus SRS Versus SRS Alone for 1-4 Brain Metastases

Completed

• Conditions: Brain Metastasis

• Registration Number: NCT00406835
• Lead Sponsor: Hokkaido University Hospital

Brief Summary

The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.

Detailed Description

Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.

Study Timeline

• Study Start: 1999-10
• Study Completion: 2005-04
• Status Verified: 2006-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Last Update Submitted: 2006-11-30
• Study First Posted: 2006-12-04
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more

Exclusion Criteria

• Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hokkaido University School of Medicine; 🇯🇵 Sapporo, Hokkaido, Japan