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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Whole brain radiation therapy arm
Salvage stereotactic radiosurgery arm
Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, Japan
overall survival
Time frame: During the study conduct
proportion of performance status (PS) preservation
Time frame: During the study conduct
proportion of mini-mental status examination (MMSE) preservation
Time frame: During the study conduct
adverse events
Time frame: During the study conduct
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Nakamura Memorial Hospital
South-1,West-14,Chuou-ku,Sapporo, Hokkaido, Japan
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan
St.Marianna University School of Medicine
Kawasaki,Miyamae-ku,Sugao,2-16-1, Kanagawa, Japan
Kumamoto University Medical School
Kumamoto,Honjo,1-1-1, Kumamoto, Japan
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan
...and 11 more locations