Status:
COMPLETED
A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Brain Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
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 wh...
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, b...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00280475
Start Date
January 1 2006
End Date
January 1 2013
Last Update
September 22 2016
Active Locations (21)
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1
Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, Japan, 466-8550
2
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
3
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan, 791-0295
4
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582