Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002708
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES
Status:
COMPLETED
Status Verified Date:
2013-11
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery
Detailed Description:
OBJECTIVES I Compare the overall survival of patients with one unresected brain metastasis treated with conventional whole brain radiotherapy WBRT with vs without a stereotactic radiosurgery SRS boost II Compare sites of recurrence and cause of death in these patients treated with WBRT followed by SRS vs WBRT alone
OUTLINE This is a randomized multicenter study Patients are stratified according to center and extracranial disease yes or no Patients are randomized to one of two treatment arms Arm I Patients receive fractionated external beam whole brain irradiation WBRT 5 days each week for 3 weeks Both portals are treated during each radiotherapy session Patients who still have a solitary lesion with a diameter no greater than 40 cm also receive stereotactic radiosurgery within 7 days of completing WBRT Arm II Patients receive WBRT only Patients are followed every 3 months for 1 year then every 4 months for 2 years and then annually
PROJECTED ACCRUAL A total of 262 patients will be accrued over 25-375 years for this study The study may close early if interim analysis after 33 and 67 of patients have been followed for 6 months produces significant results After 61499 an additional 46 patients with a solitary brain metastasis only will be accrued
OUTLINE This is a randomized multicenter study Patients are stratified according to center and extracranial disease yes or no Patients are randomized to one of two treatment arms Arm I Patients receive fractionated external beam whole brain irradiation WBRT 5 days each week for 3 weeks Both portals are treated during each radiotherapy session Patients who still have a solitary lesion with a diameter no greater than 40 cm also receive stereotactic radiosurgery within 7 days of completing WBRT Arm II Patients receive WBRT only Patients are followed every 3 months for 1 year then every 4 months for 2 years and then annually
PROJECTED ACCRUAL A total of 262 patients will be accrued over 25-375 years for this study The study may close early if interim analysis after 33 and 67 of patients have been followed for 6 months produces significant results After 61499 an additional 46 patients with a solitary brain metastasis only will be accrued
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 |
|---|---|---|---|
| CDR0000064522 | None | None | None |