UMIN-CTR Clinical Trial

Basic information
Public title	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)
Acronym	Phase III trial of postoperative WBRT vs. salvage SRT for one to four brain metastasis. JCOG0504
Scientific Title	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)
Scientific Title:Acronym	Phase III trial of postoperative WBRT vs. salvage SRT for one to four brain metastasis. JCOG0504
Region	Japan

Condition
Condition	brain neoplasms/secondary
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	overall survival
Key secondary outcomes	proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A: Whole brain radiation therapy arm Patients receive WBRT in daily 2.5Gy fractions to a total 37.5 Gy over 3 weeks. No concomitant systemic therapy is given in WBRT period.
Interventions/Control_2	B:Salvage stereotactic radiosurgery arm If patients have residual brain metastases after surgical resection, they receive SRS for residual metastases. If patients have no residual brain metastasis, they observed without radiotherapy for brain. When the recurrence or progression of residual brain metastasis is observed, patients receive salvage SRS. SRS is restricted up to 8 lesions. The SRS in our study include both Gamma Knife and LINAC-based system. Systemic therapy is permitted in the interval of SRS.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key 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 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, colorectal cancer, renal carcinoma, ovarian cancer, cervical cancer, endometrial cancer, gastric cancer or esophageal 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)
Key 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
Target sample size	270

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takamasa Kayama, MD
Organization	Yamagata University Faculty of Medicine
Division name	Department of Neurosurgery
Zip code
Address	2-2-2 Iida-nishi, Yamagata City, Yamagata 990-9585, Japan
TEL	023-628-5349
Email

Public contact
Name of contact person	1st name Middle name Last name Shinya Sato, MD, PhD
Organization	JCOG0504 Coordinating Office
Division name	Department of Neurosurgery, Yamagata University Faculty of Medicine
Zip code
Address	2-2-2 Iida-nishi, Yamagata City, Yamagata 990-9585, Japan
TEL	023-628-5349
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学病院（北海道） 中村記念病院（北海道） 岩手医科大学（岩手県） 山形大学医学部（山形県） 東北大学病院（宮城県） 千葉大学医学部（千葉県） 埼玉医科大学国際医療センター（埼玉県） 国立がん研究センター中央病院（東京都） 東京女子医科大学（東京都） 東京大学医学部（東京都） 杏林大学医学部（東京都） 慶應義塾大学病院（東京都） 名古屋大学医学部（愛知県） 京都大学医学部附属病院（京都府） 田附興風会 医学研究所 北野病院（大阪府） 広島大学病院（広島県） 愛媛大学医学部附属病院（愛媛県） 熊本大学医学部（熊本県） 九州大学病院（福岡県） 久留米大学医学部（福岡県） 筑波大学臨床医学系（茨城県） 大阪大学医学部（大阪府） 大分大学医学部附属病院（大分県） 関西医科大学附属枚方病院（大阪府） 静岡県立静岡がんセンター（静岡県） 長崎大学病院（長崎県） 鹿児島大学医学部・歯学部附属病院（鹿児島県） 日本大学医学部附属板橋病院（東京都） がん・感染症センター都立駒込病院（東京都） 兵庫医科大学（兵庫県）

Other administrative information
Date of disclosure of the study information	2006 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 11 Month 04 Day
Date of IRB	2005 Year 12 Month 19 Day
Anticipated trial start date	2006 Year 01 Month 01 Day
Last follow-up date	2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2006 Year 01 Month 18 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000389