UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000307 |
|---|---|
| Receipt number | R000000389 |
| 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) |
| Date of disclosure of the study information | 2006/01/18 |
| Last modified on | 2022/08/30 17:48:09 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000389
