UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001812 |
|---|---|
| Receipt number | 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 12:38:44 |
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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
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
gamma-knife.serizawa@nifty.com
Sponsor or person
Institute
Japan Leksell Gamma Knife Society
Institute
Department
Personal name
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
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 12.0–15.6] in the 455 patients with one tumor, 10.8 months [9.4–12.4] in the 531 patients with 2-4 tumors, and 10.8 months [9.1–12.7] 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 0.81–1.18 [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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002184
