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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000412
Receipt No. 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

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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
Institute Japanese Radiation Oncology Study Group
Institute
Department

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
URL(English) https://upload.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


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