Gamma knife treatment results for patients with multiple brain metastases: A multi-institutional prospective study

Not Applicable

• Conditions: Metastatic brain tumor

• Registration Number: JPRN-UMIN000001812
• Lead Sponsor: Japan Leksell Gamma Knife Society

Brief Summary

We enrolled 1194 eligible patients. Median overall survival times after stereotactic radiosurgery were 13.9 months [95% CI 12.0–15.6] in the 455 patients with one tumor, 10.8 months [9.4–12.4] in the 531 patients with 2-4 tumors, and 10.8 months [9.1–12.7] in the 208 patients with 5-10 tumors. Overall survival times did not differ between the patients with 2-4 tumors and those with 5-10 (HR 0.97, 95% CI 0.81–1.18 [less than non-inferiority margin], p=0.78; P (non-inferiority) <0.0001). The proportion of patients who had treatment-related adverse event of grade 1-5 did not differ significantly between the two groups, tumor numbers 2-4 and 5-10. Our results show that stereotactic radiosurgery without WBRT in patients with 5-10 brain metastases is non-inferior to that in patients with 2-4 brain metastases.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-30
• Study Completion: 2012-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

1) active double cancer 2) in pregnancy or lactation period 3) psychiatric disorder 4) Allergy to gadolinium contrast or contraindication of MR imaging

Study & Design

• Study Type: Observational
• Study Design: Not specified