Unique ID issued by UMIN | C000000412 |
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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 |
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
Phase III trial between SRS-alone vs. WBRT+SRS for 1-4 brain mets.
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
Phase III trial between SRS-alone vs. WBRT+SRS for 1-4 brain mets.
Japan |
1-4 brain metastases, each less than 3cm
Radiology |
Malignancy
NO
To determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.
Safety,Efficacy
Confirmatory
Explanatory
Phase III
overall survival
brain tumor recurrence (BTR), salvage brain treatment, functional preservation, radiation toxicity, and cause of death
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Maneuver |
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.
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.
18 | years-old | <= |
Not applicable |
Male and Female
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.
Age<18
KPS<70
Pathology: small cell carcinoma, lymphoma, germinoma, and multiple myeloma
180
1st name | |
Middle name | |
Last name | Hidefumi Aoyama |
Hokkaido University School of Medicine
Radiology
North 14, West 7, Kita-ku, Sapporo
011-706-5977
1st name | |
Middle name | |
Last name | Hidefumi Aoyama |
Hokkaido University
Radiology
North 14, West 7, Kita-ku, Sapporo
011-706-5977
h-aoyama@umin.ac.jp
Japanese Radiation Oncology Study Group
Japanese Radiation Oncology Study Group
Non profit foundation
Japan
YES
JROSG99-1
Japanese Radiation Oncology Study Group
2006 | Year | 05 | Month | 01 | Day |
http://www.jrosg.jp/
Published
http://jama.ama-assn.org/cgi/content/abstract/295/21/2483
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.
Completed
1999 | Year | 08 | Month | 16 | Day |
1999 | Year | 10 | Month | 01 | Day |
2005 | Year | 04 | Month | 01 | Day |
2005 | Year | 04 | Month | 01 | Day |
2005 | Year | 04 | Month | 01 | Day |
2005 | Year | 05 | Month | 01 | Day |
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.
2006 | Year | 05 | Month | 01 | Day |
2015 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000501
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