UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022152 |
|---|---|
| Receipt number | R000025522 |
| Scientific Title | Staged gamma knife radiosurgery for patients with large brain metastases: A multi-institutional retrospective study |
| Date of disclosure of the study information | 2016/04/30 |
| Last modified on | 2018/10/31 18:34:42 |
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Basic information
Public title
Staged gamma knife radiosurgery for patients with large brain metastases:
A multi-institutional retrospective study
Acronym
Staged gamma knife radiosurgery for patients with large brain metastases
Scientific Title
Staged gamma knife radiosurgery for patients with large brain metastases:
A multi-institutional retrospective study
Scientific Title:Acronym
Staged gamma knife radiosurgery for patients with large brain metastases
Region
| Japan |
Condition
Condition
Metastatic brain tumors
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Stereotactic radiosurgery (SRS) has a critical role in the treatment of brain metastases; however, a large tumor volume is not suitable for SRS. Local tumor control is reportedly unsatisfactory for metastatic brain tumors exceeding 10 cm3 in diameter. Fractionated stereotactic radiotherapy has been used as a treatment option for large brain metastases in patients with surgical contraindications; however, there is as yet no standard procedure for dose fractionation in stereotactic irradiation for brain metastases. The purpose of this study is to evaluate results of staged gamma knife radiosurgery for large brain metastases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
1) Functional preserved survival
2) Additional treatments
3) Local tumor control
4) Treatment-related adverse events
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
Patients having metastatic brain tumors treated with staged gamma knife radiosurgery until end of December 2015.
The included patients meet the following criteria:
1) newly diagnosed brain metastases
2) maximum total treatment period of 6 weeks
3) minimum interval between fractions of 12 days
4) Prescribed dose 9-11 Gy for 3 staged or 11.8-14.3 Gy for 2 staged gamma knife radiosurgery
5) KPS more than and equal to 70, or KPS less than 70 due to neurological symptom
6) maximum volume of 33.5 cm3
7) up to 10 brain tumors
8) maximum total tumor volume of 50 cm3
9) patient's head secured with Leksel G frame
10) no finding of meningeal seeding or carcinomatous meningitis on MRI
11) one or more available follow-up MRI
Key exclusion criteria
Patients with brain tumors of unknown origin, brain metastases of sarcoma, malignant lymphoma are excluded in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Serizawa |
Organization
Tsukiji Neurological Clinic
Division name
Tokyo Gamma Unit Center
Zip code
Address
Tsukiji 1-9-9, Chuo-ku, Tokyo
TEL
03-6226-3546
gamma-knife.serizawa@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Higuchi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Neurological Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-226-2158
Homepage URL
yhiguchi@faculty.chiba-u.jp
Sponsor or person
Institute
Japanese Leksell Gamma Knife Society
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
JLGK1601
Org. issuing International ID_1
Japanese 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
| 2016 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30192195
Number of participants that the trial has enrolled
Results
In the case-matched cohort, post-GKS median survival time tended to be longer in the 3-stage group (15.9 months) than in the 2-stage group (11.7 months), but the difference was not statistically significant (p = 0.65). The cumulative incidences of tumor progression (21.6% vs 16.7% at 1 year, p = 0.31), neurological death (5.1% vs 6.0% at 1 year, p = 0.58), or serious radiation-related adverse events (3.0% vs 4.0% at 1 year, p = 0.49) did not differ significantly. CONCLUSIONS This retrospective multi-institutional study showed no differences between 3-stage and 2-stage GKS in terms of overall survival, tumor progression, neurological death, and radiation-related adverse events. Both 3-stage and 2-stage GKS performed according to the aforementioned protocols are good treatment options in selected patients with large BMs.
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
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following parameter will be analyzed to obtain an optimal treatment protocol:
1) presence of genetic mutation of the primary cancer
2) treatment of primary cancer
3) interval between diagnosis of brain metastases and the treatment
4) KPS at the treatment
5) control of primary cancer
6) extra cranial metastases
7) neurological symptoms
8) number of brain metastases
9) maximum tumor diameter and total tumor volume
10) treatment parameters (fractions, inter fraction interval, prescribed dose etc.)
Management information
Registered date
| 2016 | Year | 04 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025522
