A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
Conditions
Brain Neoplasms - Neoplasm Metastasis
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis - Neoplasms
Conditions: Keywords
Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Whole brain radiation therapy arm Type: Device
Name: Salvage stereotactic radiosurgery arm Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. 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

2. all brain metastases localized within cerebrum or cerebellum

3. before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits

4. surgical resection for the largest brain metastases has achieved

5. after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm

6. histologically proven non-small cell carcinoma, breast cancer or colorectal cancer

7. primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled

8. an age of 20-79 years

9. no prior surgery or irradiation for brain

10. adequate organ function

11. 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)

Exclusion Criteria:

1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer

2. pregnant or breast-feeding women

3. severe mental disease

4. allergic to gadolinium contained contrast agents
Locations
Nagoya University School of Medicine
65 Tsurumai-cho,Showa-ku,Nagoya, Aichi, Japan
Status: Recruiting
Contact: Toshihiko Wakabayashi, M.D., Ph.D. - 81-52-744-2355
Chiba University, Graduate School of Medicine
1-8-1,Inohana,Chuo-ku,Chiba, Chiba, Japan
Status: Recruiting
Contact: Yasuo Iwadate, M.D. - 81-43-226-2158
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan
Status: Recruiting
Contact: Hironobu Harada, M.D. - 81-89-960-5338
Kyushu University Hospital
3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan
Status: Recruiting
Contact: Tadahisa Shono, M.D., Ph.D. - 81-92-642-5524
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Status: Recruiting
Contact: Yutaka Sawamura, M.D., Ph.D - 81-11-706-5987
Nakamura Memorial Hospital
South-1,West-14,Chuou-ku,Sapporo, Hokkaido, Japan
Status: Recruiting
Contact: Tamio Ito, M.D. - 81-11-231-8555
Iwate Medical University
19-1,Uchimaru,Morioka, Iwate, Japan
Status: Recruiting
Contact: Takaaki Beppu, M.D. - 81-19-651-5111
St.Marianna University School of Medicine
2-16-1,Sugao,Miyamae-ku,Kawasaki, Kanagawa, Japan
Status: Recruiting
Contact: Katsuyuki Tanaka, M.D. - 81-44-977-8111
Kumamoto University Medical School
1-1-1,Honjo,Kumamoto, Kumamoto, Japan
Status: Recruiting
Contact: Hideo Nakamura, M.D., Ph.D. - 81-96-373-5219
Kyoto University Hospital
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan
Status: Recruiting
Contact: Jun Takahashi, M.D., Ph.D. - 81-75-751-3459
Tohoku University Hospital
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan
Status: Recruiting
Contact: Toshihiro Kumabe, M.D. - 81-22-717-7230
Niigata University Medical and Dental Hospital
1-754,Asahimachi-dori,Niigata, Niigata, Japan
Status: Recruiting
Contact: Hideaki Takahashi, M.D. - 81-25-227-0652
Saitama Medical School Hospital
38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan
Status: Recruiting
Contact: Kazuhiko Mishima, M.D. - 81-49-276-1334
Teikyo University School of Medicine
2-11-1,Kaga,Itabashi-ku, Tokyo, Japan
Status: Recruiting
Contact: Takamitsu Fujimaki, M.D. - 81-3-3964-2415
Keio University Hospital
35,Shinanomachi,Shinjuku-ku, Tokyo, Japan
Status: Recruiting
Contact: Takahito Yazaki, M.D., Ph.D. - 81-3-5363-3808
National Cancer Center Hospital
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan
Status: Recruiting
Contact: Soichiro Shibui, M.D., Ph.D. - 81-3-3542-2511
Kyorin University School of Medicine
6-20-2,Shinkawa,Mitaka, Tokyo, Japan
Status: Recruiting
Contact: Motoo Nagane, M.D., Ph.D - 81-422-47-5511
The University of Tokyo Hospital
7-3-1,Hongo,Bunkyo-ku, Tokyo, Japan
Status: Recruiting
Contact: Minoru Tanaka, M.D., Ph.D - 81-3-5800-8853
Tokyo Women's Medical University
8-1,Kawada-cho,Shinjuku-ku, Tokyo, Japan
Status: Recruiting
Contact: Yoshihiro Muragaki, M.D. - 81-3-3353-8111
Yamagata University Faculty of Medicine
2-2-2 Iida-nishi, Yamagata City, Yamagata, Japan
Status: Recruiting
Contact: Kaori Sakurada, MD, PhD - 81-23-628-5349
University of Yamanashi Faculty of Medicine
1110,Shimokato,Tamaho,Nakakoma, Yamanashi, Japan
Status: Recruiting
Contact: Eiji Satoh, M.D. - 81-55-273-6786
Start Date
January 2006
Completion Date
January 2013
Sponsors
Japan Clinical Oncology Group
Source
Japan Clinical Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page