UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000412
Receipt number R000000501
Scientific Title Multi-institutional Prospective Randomized Comparison of Stereotactic Radiosurgery plus Upfront Whole Brain Radiation Therapy versus Stereotactic Radiosurgery Alone for the treatment of Solitary and Multiple Brain Metastases
Date of disclosure of the study information 2006/05/01
Last modified on 2015/10/06 10:15:36

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Basic information

Public title

Multi-institutional Prospective Randomized Comparison of Stereotactic Radiosurgery plus Upfront Whole Brain Radiation Therapy versus Stereotactic Radiosurgery Alone for the treatment of Solitary and Multiple Brain Metastases

Acronym

Phase III trial between SRS-alone vs. WBRT+SRS for 1-4 brain mets.

Scientific Title

Multi-institutional Prospective Randomized Comparison of Stereotactic Radiosurgery plus Upfront Whole Brain Radiation Therapy versus Stereotactic Radiosurgery Alone for the treatment of Solitary and Multiple Brain Metastases

Scientific Title:Acronym

Phase III trial between SRS-alone vs. WBRT+SRS for 1-4 brain mets.

Region

Japan


Condition

Condition

1-4 brain metastases, each less than 3cm

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

brain tumor recurrence (BTR), salvage brain treatment, functional preservation, radiation toxicity, and cause of death


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Stereotactic Radiosurgery (SRS) alone
The SRS dose was prescribed to the tumor margin. Metastases with a maximum diameter of up to 2 cm were treated with 22-25 Gy, and those larger than 2 cm were treated with 18-20 Gy.

Interventions/Control_2

Whole Brain Radiotherapy plus SRS.
The WBRT schedule was 30 Gy in 10 fractions over 2 to 2.5 weeks. SRS dose was 30% reduced from SRS-alone arm.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, derived from a histologically confirmed systemic cancer.

Key exclusion criteria

Age<18
KPS<70
Pathology: small cell carcinoma, lymphoma, germinoma, and multiple myeloma

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidefumi Aoyama

Organization

Hokkaido University School of Medicine

Division name

Radiology

Zip code


Address

North 14, West 7, Kita-ku, Sapporo

TEL

011-706-5977

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hidefumi Aoyama

Organization

Hokkaido University

Division name

Radiology

Zip code


Address

North 14, West 7, Kita-ku, Sapporo

TEL

011-706-5977

Homepage URL


Email

h-aoyama@umin.ac.jp


Sponsor or person

Institute

Japanese Radiation Oncology Study Group

Institute

Department

Personal name



Funding Source

Organization

Japanese Radiation Oncology Study Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

JROSG99-1

Org. issuing International ID_1

Japanese Radiation Oncology 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

2006 Year 05 Month 01 Day


Related information

URL releasing protocol

http://www.jrosg.jp/

Publication of results

Published


Result

URL related to results and publications

http://jama.ama-assn.org/cgi/content/abstract/295/21/2483

Number of participants that the trial has enrolled


Results

Randomized controlled trial of 132 patients with 1 to 4 brain metastases, each less than 3 cm in diameter, randomized between October 1999 and December 2003. Patients were randomized to receive WBRT plus SRS (65 patients) or SRS alone (67 patients) for brain metastases. The median survival time and the 1-year actuarial survival rate were 7.5 months and 38.5% in the WBRT plus SRS arm and 8.0 months in and 28.4% for the SRS-alone arm (P=0.42). The 12-month BTR rate was 46.8% in the WBRT plus SRS arm and 76.4% in the SRS-alone arm (P<0.001). Salvage brain treatment was less frequently required in the WBRT+SRS arm (15%) than in the SRS-alone arm (43%)(P<0.001). Death was attributed to neurologic causes in 22.8% of patients in the WBRT plus SRS arm and in 19.3% of those in the SRS-alone arm. There were no significant differences in systemic and neurologic functional preservation, and radiation toxicity.

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

Completed

Date of protocol fixation

1999 Year 08 Month 16 Day

Date of IRB


Anticipated trial start date

1999 Year 10 Month 01 Day

Last follow-up date

2005 Year 04 Month 01 Day

Date of closure to data entry

2005 Year 04 Month 01 Day

Date trial data considered complete

2005 Year 04 Month 01 Day

Date analysis concluded

2005 Year 05 Month 01 Day


Other

Other related information

ASCO 2004 in New Orleans

Initial Analysis:
1.JAMA. 2006;295(21):2483-2491. doi:10.1001/jama.295.21.2483.
2.Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1388-95. doi:10.1016/j.ijrobp.2007.03.048

Secondary analysis:
JAMA Oncol. 2015;1(4):457-464. doi:10.1001/jamaoncol.2015.1145.


Management information

Registered date

2006 Year 05 Month 01 Day

Last modified on

2015 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000501


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name