Neoplasm Metastasis Clinical Trial
Official title:
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)
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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