Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002899
Status:
TERMINATED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
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 Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases
PURPOSE This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors
PURPOSE This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors
Detailed Description:
OBJECTIVES
Primary
Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer
Secondary
Determine overall survival and progression-free survival of patients treated on this protocol
Determine time to neurologic progression in patients treated on this protocol
Determine quality of life of patients treated on this protocol
OUTLINE This is a randomized multicenter study Patients are stratified by participating center number of brain metastases single vs multiple type of primary tumor stable systemic cancer vs synchronous or unknown primary WHO performance status 0-1 vs 2 and treatment prior surgical resection vs planned radiosurgery
Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery
Arm I Patients undergo adjuvant whole brain radiotherapy WBRT
Arm II Patients do not receive adjuvant radiotherapy Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms
Arm III Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery
Arm IV Patients undergo radiosurgery alone Quality of life is assessed at baseline at 8 weeks and then every 3 months thereafter
After completion if study treatment patients are followed at 8 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 340 patients 85 per treatment arm will be accrued for this study within 35 years
Primary
Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer
Secondary
Determine overall survival and progression-free survival of patients treated on this protocol
Determine time to neurologic progression in patients treated on this protocol
Determine quality of life of patients treated on this protocol
OUTLINE This is a randomized multicenter study Patients are stratified by participating center number of brain metastases single vs multiple type of primary tumor stable systemic cancer vs synchronous or unknown primary WHO performance status 0-1 vs 2 and treatment prior surgical resection vs planned radiosurgery
Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery
Arm I Patients undergo adjuvant whole brain radiotherapy WBRT
Arm II Patients do not receive adjuvant radiotherapy Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms
Arm III Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery
Arm IV Patients undergo radiosurgery alone Quality of life is assessed at baseline at 8 weeks and then every 3 months thereafter
After completion if study treatment patients are followed at 8 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 340 patients 85 per treatment arm will be accrued for this study within 35 years
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 |
|---|---|---|---|
| EORTC-26001 | None | None | None |
| EORTC-22952 | None | None | None |