A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
Randomized Phase III Trial of Postoperative Whole Brain Radiation Therapy Compared With Salvage Stereotactic Radiosurgery in Patients With One to Four Brain Metastasis: Japan Clinical Oncology Group Study (JCOG 0504)
2 other identifiers
interventional
270
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2006
Longer than P75 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 20, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedSeptember 22, 2016
September 1, 2016
7 years
January 20, 2006
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
During the study conduct
Secondary Outcomes (3)
proportion of performance status (PS) preservation
During the study conduct
proportion of mini-mental status examination (MMSE) preservation
During the study conduct
adverse events
During the study conduct
Study Arms (2)
1
ACTIVE COMPARATORDevice: Whole brain radiation therapy arm
2
EXPERIMENTALDevice: Salvage stereotactic radiosurgery arm
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (21)
Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, 466-8550, Japan
Chiba University, Graduate School of Medicine
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
Related Publications (1)
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.
PMID: 39305441DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Takamasa Kayama, MD, PhD
Yamagata University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
January 20, 2006
First Posted
January 23, 2006
Study Start
January 1, 2006
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
September 22, 2016
Record last verified: 2016-09