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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001812
Receipt No. R000002184
Scientific Title Gamma knife treatment results for patients with multiple brain metastases: A multi-institutional prospective study
Date of disclosure of the study information 2009/03/30
Last modified on 2019/06/22

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Basic information
Public title Gamma knife treatment results for patients with multiple brain metastases: A multi-institutional prospective study
Acronym Multi-institutional prospective study of gamma knife surgery for brain metastases
Scientific Title Gamma knife treatment results for patients with multiple brain metastases: A multi-institutional prospective study
Scientific Title:Acronym Multi-institutional prospective study of gamma knife surgery for brain metastases
Region
Japan

Condition
Condition Metastatic brain tumor
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective study is to evaluate results of a treatment protocol using gamma knife surgery for brain metastases without upfront whole brain irradiation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Local tumor control, functional preservation, KPS, MMSE, distant recurrence, additional treatment

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) a maximum of 10 tumors
2) maximum diameter 30 mm or maximum tumor volume of 10 cc
3) no evidence of CSF dissemination on MRI
4) maximum total tumor volume of 15 cc
5) any histological diagnosis of primary tumor except sarcoma or lymphoma
6) KPS>=70 of KPS<70 due to neurological symptom
7) no past history of cranial radiation therapy or craniotomy
Key exclusion criteria 1) active double cancer
2) in pregnancy or lactation period
3) psychiatric disorder
4) Allergy to gadolinium contrast or contraindication of MR imaging
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Yamamoto
Organization Katsuta Hospital
Division name Mito Gamma House
Zip code
Address 5125-2 Nakane, Hitachi-naka, Ibaraki 312-0011 Japan
TEL 029-271-0011
Email BCD06275@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Toru Serizawa
Organization Tsukiji Neurological Clinic
Division name Tokyo Gamma Unit Center
Zip code
Address 1-9-9 Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL 03-6226-3546
Homepage URL
Email gamma-knife.serizawa@nifty.com

Sponsor
Institute Japan Leksell Gamma Knife Society
Institute
Department

Funding Source
Organization Japan Brain Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JLGK0901
Org. issuing International ID_1 Japan Leksell Gamma Knife Society Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70061-0/fulltext
Number of participants that the trial has enrolled
Results
We enrolled 1194 eligible patients. Median overall survival times after stereotactic radiosurgery were 13.9 months [95% CI 12.0&#8211;15.6] in the 455 patients with one tumor, 10.8 months [9.4&#8211;12.4] in the 531 patients with 2-4 tumors, and 10.8 months [9.1&#8211;12.7] in the 208 patients with 5-10 tumors. Overall survival times did not differ between the patients with 2-4 tumors and those with 5-10 (HR 0.97, 95% CI 0.81&#8211;1.18 [less than non-inferiority margin], p=0.78; P (non-inferiority) <0.0001). The proportion of patients who had treatment-related adverse event of grade 1-5 did not differ significantly between the two groups, tumor numbers 2-4 and 5-10. Our results show that stereotactic radiosurgery without WBRT in patients with 5-10 brain metastases is non-inferior to that in patients with 2-4 brain metastases.
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 Main results already published
Date of protocol fixation
2009 Year 02 Month 07 Day
Date of IRB
2009 Year 01 Month 31 Day
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 01 Month 05 Day
Date trial data considered complete
2013 Year 01 Month 15 Day
Date analysis concluded
2013 Year 02 Month 01 Day

Other
Other related information The aim of this prospective study is to evaluate results of gamma knife surgery for brain metastases using a standard protocol for indication, dose planning, and follow up. These results will demonstrate indication for and limitations of and gamma knife surgery for brain metastases.

Management information
Registered date
2009 Year 03 Month 29 Day
Last modified on
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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