A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
- Conditions
- Neoplasm MetastasisBrain Neoplasms
- Interventions
- Device: Salvage stereotactic radiosurgery armDevice: Whole brain radiation therapy arm
- Registration Number
- NCT00280475
- Lead Sponsor
- Haruhiko Fukuda
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter
- all brain metastases localized within cerebrum or cerebellum
- before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits
- surgical resection for the largest brain metastases has achieved
- after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm
- histologically proven non-small cell carcinoma, breast cancer or colorectal cancer
- primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled
- an age of 20-79 years
- no prior surgery or irradiation for brain
- adequate organ function
- written informed consent(If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted)
- synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer
- pregnant or breast-feeding women
- severe mental disease
- allergic to gadolinium contained contrast agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Salvage stereotactic radiosurgery arm Device: Salvage stereotactic radiosurgery arm 1 Whole brain radiation therapy arm Device: Whole brain radiation therapy arm
- Primary Outcome Measures
Name Time Method overall survival During the study conduct
- Secondary Outcome Measures
Name Time Method adverse events During the study conduct proportion of mini-mental status examination (MMSE) preservation During the study conduct proportion of performance status (PS) preservation During the study conduct
Trial Locations
- Locations (21)
Nagoya University School of Medicine
🇯🇵Nagoya,Showa-ku,Tsurumai-cho,65, Aichi, Japan
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
Iwate Medical University
🇯🇵Morioka,Uchimaru,19-1, Iwate, Japan
Nakamura Memorial Hospital
🇯🇵South-1,West-14,Chuou-ku,Sapporo, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Kumamoto University Medical School
🇯🇵Kumamoto,Honjo,1-1-1, Kumamoto, Japan
Kyoto University Hospital
🇯🇵Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan
St.Marianna University School of Medicine
🇯🇵Kawasaki,Miyamae-ku,Sugao,2-16-1, Kanagawa, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata,Asahimachi-dori,1-754, Niigata, Japan
Tohoku University Hospital
🇯🇵Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Saitama Medical School Hospital
🇯🇵Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
Kyorin University School of Medicine
🇯🇵Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Yamagata University Faculty of Medicine
🇯🇵Yamagata City,Iida-nishi, 2-2-2, Yamagata, Japan
University of Yamanashi Faculty of Medicine
🇯🇵Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan
Teikyo University School of Medicine
🇯🇵Itabashi-ku,Kaga,2-11-1, Tokyo, Japan
Tokyo Women's Medical University
🇯🇵Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan