Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030628
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2002-02-14
Brief Title:
Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
Status:
COMPLETED
Status Verified Date:
2016-07
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 Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases
PURPOSE Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases
PURPOSE Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy
Compare the time to CNS failure brain in patients treated with these regimens
Compare the quality of life duration of functional independence and long-term neurocognitive status in patients treated with these regimens
Compare the post-treatment toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age 60 and over vs under 60 extracranial disease controlled for more than 3 months vs controlled for 3 months or less and number of brain metastases 1 vs more than 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiosurgery
Arm II Patients undergo radiosurgery Within 14 days patients then undergo whole brain radiotherapy 5 days a week for 25 weeks
Quality of life is assessed at baseline the beginning of each treatment at week 6 every 3 months for 1 year every 4 months for 1 year and then every 6 months for 2 years
Patients are followed at weeks 6 and 12 every 3 months for 9 months every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 480 patients 240 per treatment arm will be accrued for this study within 5 years
Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy
Compare the time to CNS failure brain in patients treated with these regimens
Compare the quality of life duration of functional independence and long-term neurocognitive status in patients treated with these regimens
Compare the post-treatment toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age 60 and over vs under 60 extracranial disease controlled for more than 3 months vs controlled for 3 months or less and number of brain metastases 1 vs more than 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiosurgery
Arm II Patients undergo radiosurgery Within 14 days patients then undergo whole brain radiotherapy 5 days a week for 25 weeks
Quality of life is assessed at baseline the beginning of each treatment at week 6 every 3 months for 1 year every 4 months for 1 year and then every 6 months for 2 years
Patients are followed at weeks 6 and 12 every 3 months for 9 months every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 480 patients 240 per treatment arm will be accrued for this study within 5 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 |
|---|---|---|---|
| CDR0000069183 | OTHER | NCI Physician Data Query | None |
| ACOSOG-Z0300 | None | None | None |