Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280475
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2006-01-20
Brief Title:
A Trial of Postoperative Whole Brain Radiation Therapy vs Salvage Stereotactic Radiosurgery Therapy for Metastasis
Sponsor:
Haruhiko Fukuda
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Randomized Phase III Trial of Postoperative Whole Brain Radiation Therapy Compared With Salvage Stereotactic Radiosurgery in Patients With One to Four Brain Metastasis Japan Clinical Oncology Group Study JCOG 0504
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery SRS in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy WBRT
Detailed Description:
A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung breast and colorectal cancer
Total of 270 patients will be accrued for this study from 21 institutions within three years The primary endpoint is overall survival The secondary endpoints are proportion of performance status PS preservation proportion of mini-mental status examination MMSE preservation and adverse events
Total of 270 patients will be accrued for this study from 21 institutions within three years The primary endpoint is overall survival The secondary endpoints are proportion of performance status PS preservation proportion of mini-mental status examination MMSE preservation and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C000000307 | REGISTRY | UMIN-CTR | None |