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| ID | Type | Description | Link |
|---|---|---|---|
| C000000307 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Ministry of Health, Labour and Welfare, Japan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Device: Whole brain radiation therapy arm |
|
| 2 | Experimental | Device: Salvage stereotactic radiosurgery arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole brain radiation therapy arm | Device | Whole brain radiation therapy arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | During the study conduct |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of performance status (PS) preservation | During the study conduct | |
| proportion of mini-mental status examination (MMSE) preservation | During the study conduct | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takamasa Kayama, MD, PhD | Yamagata University Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University School of Medicine | Nagoya,Showa-ku,Tsurumai-cho,65 | Aichi-ken | 466-8550 | Japan | ||
| Chiba University, Graduate School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39305441 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Salvage stereotactic radiosurgery arm |
| Device |
Salvage stereotactic radiosurgery arm |
|
| adverse events |
| During the study conduct |
| Chiba,Chuo-ku,Inohana,1-8-1 |
| Chiba |
| 260-8670 |
| Japan |
| Ehime University Hospital | Shitsukawa,Toon | Ehime | 791-0295 | Japan |
| Kyushu University Hospital | Higashi-ku,Maidashi,3-1-1 | Fukuoka | 812-8582 | Japan |
| Hokkaido University Hospital | North-14 West-5 Kita-ku,Sapporo | Hokkaido | 060-8648 | Japan |
| Nakamura Memorial Hospital | South-1,West-14,Chuou-ku,Sapporo | Hokkaido | 060-8570 | Japan |
| Iwate Medical University | Morioka,Uchimaru,19-1 | Iwate | 020-8505 | Japan |
| St.Marianna University School of Medicine | Kawasaki,Miyamae-ku,Sugao,2-16-1 | Kanagawa | 216-8511 | Japan |
| Kumamoto University Medical School | Kumamoto,Honjo,1-1-1 | Kumamoto | 860-8556 | Japan |
| Kyoto University Hospital | Kyoto,Sakyo-ku,Syogoinkawara,54 | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital | Sendai,Aoba-ku,Seiryo-machi,1-1 | Miyagi | 980-8574 | Japan |
| Niigata University Medical and Dental Hospital | Niigata,Asahimachi-dori,1-754 | Niigata | 951-8520 | Japan |
| Saitama Medical School Hospital | Iruma-gun,Moroyama-machi,Morohongo,38 | Saitama | 350-0495 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku,Hongo,7-3-1 | Tokyo | 113-8655 | Japan |
| National Cancer Center Hospital | Chuo-ku,Tsukiji,5-1-1 | Tokyo | 104-0045 | Japan |
| Teikyo University School of Medicine | Itabashi-ku,Kaga,2-11-1 | Tokyo | 173-8605 | Japan |
| Kyorin University School of Medicine | Mitaka,Shinkawa,6-20-2 | Tokyo | 181-8611 | Japan |
| Tokyo Women's Medical University | Shinjuku-ku,Kawada-cho,8-1 | Tokyo | 162-8666 | Japan |
| Keio University Hospital | Shinjuku-ku,Shinanomachi,35 | Tokyo | 160-8582 | Japan |
| Yamagata University Faculty of Medicine | Yamagata City,Iida-nishi, 2-2-2 | Yamagata | 990-585 | Japan |
| University of Yamanashi Faculty of Medicine | Nakakoma,Tamaho,Shimokato,1110 | Yamanashi | 409-3898 | Japan |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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