UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009055
Receipt number R000010628
Scientific Title Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)
Date of disclosure of the study information 2012/10/09
Last modified on 2019/04/12 12:50:06

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Basic information

Public title

Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)

Acronym

Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)

Scientific Title

Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)

Scientific Title:Acronym

Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)

Region

Japan


Condition

Condition

Brain metastases

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the feasibility of low-dose whole brain radiotherapy (25 Gy in 10 fractions) combined with stereotactic irradiation for 1-4 brain metastatic patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Development rate of distant brain metastases at 6-month after treatment

Key secondary outcomes

1) Neurocognitive function at 4-month
2) Neurocognitive function at 12-month
3) Local tumor control of brain metastases
4) Overall survival
5) Cause of death


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Low-dose whole brain radiotherapy (25 Gy in 10 fractions)

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Age: 20-80 years old
2) Systemic status: KPS >= 70
3) Histopathologically confirmed
3) Indication for stereotactic irradiation (number of brain metastases, 4 or less, maximum tumor diameter, 3 cm of less)
5) Consent to neurocognitive fuctional tests and QOL questionnaire
6) Consent to this study

Key exclusion criteria

1) severe decline in neurocognitive function or language ability at baseline
2) history of brain radiation therapy
3) history of brain surgery of brain metastases
4) small cell carcinoma, germinoma, lymphoma
5) any other reasons not to fit to this study

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Hidefumi
Middle name
Last name Aoyama

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Radiology

Zip code

9518510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata, 9518510

TEL

025-227-2315

Email

jrosg13-1@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Hidefumi
Middle name
Last name Aoyama

Organization

Niigata Univerisity Graduate School of Medical and Dental Sciences

Division name

Radiology

Zip code

9518510

Address

1-757 Asahimachi-dori, Chuo-ku, 9518510

TEL

025-227-2315

Homepage URL

http://www.jrosg.jp/protocol/protocol_list.html

Email

jrosg13-1@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University, Dept of Radiology,

Japanese Radiation Oncology Study Group

Institute

Department

Personal name



Funding Source

Organization

JSJP

Niigata University Funding for Support for Clinical Study

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University Hospital

Address

1-754 Asahimachi-dori, Niigata

Tel

025-227-0730

Email

smaru@dent.niigata-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

JROSG 13-1

Org. issuing International ID_1

Japanese Radiation Oncology Study Group

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

新潟大学医歯学総合研究科(新潟県)、県立がんセンター新潟病院(新潟県)、琉球大学附属病院(沖縄県)、埼玉県立がんセンター(埼玉県)、国立がん研究センター中央病院(東京)、熊本大学、北海道大学(北海道)、北海道がんセンター(北海道)


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 09 Day


Related information

URL releasing protocol

http://www.jrosg.jp/protocol/file/JROSG13-1_20150630-2.pdf

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

No longer recruiting

Date of protocol fixation

2012 Year 03 Month 28 Day

Date of IRB

2012 Year 03 Month 28 Day

Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2019 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 10 Month 06 Day

Last modified on

2019 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010628


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name