A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
NCT ID: NCT00280475
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2006-01-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Device: Whole brain radiation therapy arm
Whole brain radiation therapy arm
Whole brain radiation therapy arm
2
Device: Salvage stereotactic radiosurgery arm
Salvage stereotactic radiosurgery arm
Salvage stereotactic radiosurgery arm
Interventions
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Whole brain radiation therapy arm
Whole brain radiation therapy arm
Salvage stereotactic radiosurgery arm
Salvage stereotactic radiosurgery arm
Eligibility Criteria
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Inclusion Criteria
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
2. pregnant or breast-feeding women
3. severe mental disease
4. allergic to gadolinium contained contrast agents
20 Years
79 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
Principal Investigators
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Takamasa Kayama, MD, PhD
Role: STUDY_CHAIR
Yamagata University Faculty of Medicine
Locations
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Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, 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
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
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, Japan
Saitama Medical School Hospital
Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan
The University of Tokyo Hospital
Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Teikyo University School of Medicine
Itabashi-ku,Kaga,2-11-1, Tokyo, Japan
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, 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
Countries
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References
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Simeoli C, Di Paola N, Stigliano A, Lardo P, Kearney T, Mezosi E, Ghigo E, Giordano R, Mariash CN, Donegan DM, Feelders RA, Hand AL, Araque KA, Moraitis AG, Pivonello R. Relacorilant or surgery improved hemostatic markers in Cushing syndrome. J Endocrinol Invest. 2025 Mar;48(3):671-680. doi: 10.1007/s40618-024-02468-2. Epub 2024 Sep 21.
Related Links
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Related Info
Other Identifiers
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C000000307
Identifier Type: REGISTRY
Identifier Source: secondary_id
JCOG0504
Identifier Type: -
Identifier Source: org_study_id
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