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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name