NCT00280475

A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis

Randomized Phase III Trial of Postoperative Whole Brain Radiation Therapy Compared With Salvage Stereotactic Radiosurgery in Patients With One to Four Brain Metastasis: Japan Clinical Oncology Group Study (JCOG 0504)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Haruhiko Fukuda · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (SRS) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (WBRT).

Detailed description

A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer. Total of 270 patients will be accrued for this study from 21 institutions within three years. The primary endpoint is overall survival. The secondary endpoints are proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.

Conditions

• Brain Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DEVICE	Whole brain radiation therapy arm	Whole brain radiation therapy arm
DEVICE	Salvage stereotactic radiosurgery arm	Salvage stereotactic radiosurgery arm

Timeline

• Start date: 2006-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2006-01-23
• Last updated: 2016-09-22

Locations

21 sites across 1 country: Japan