Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033254
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2002-04-09
Brief Title:
Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Conventional Radiation Therapy Plus Thalidomide NSC66847 Versus Conventional Radiation Therapy for Multiple Brain Metastases
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases
Detailed Description:
OBJECTIVES
I Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide
II Compare the time to tumor progression in patients treated with these regimens
III Compare the time to neuro-cognitive progression in patients treated with these regimens
IV Compare the cause of death distribution in patients treated with these regimens
V Compare the frequency of toxic effects of these regimens in these patients VI Evaluate and compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to recursive partitioning analysis class I vs II and planned chemotherapy after whole brain irradiation yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for 3 weeks Arm II Patients undergo radiotherapy as in arm I Beginning on the first day of radiotherapy patients receive oral thalidomide once daily
Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at completion of radiotherapy and then every 2 months for 1 year
Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 332 patients 166 per treatment arm will be accrued for this study within 145 months
I Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide
II Compare the time to tumor progression in patients treated with these regimens
III Compare the time to neuro-cognitive progression in patients treated with these regimens
IV Compare the cause of death distribution in patients treated with these regimens
V Compare the frequency of toxic effects of these regimens in these patients VI Evaluate and compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to recursive partitioning analysis class I vs II and planned chemotherapy after whole brain irradiation yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for 3 weeks Arm II Patients undergo radiotherapy as in arm I Beginning on the first day of radiotherapy patients receive oral thalidomide once daily
Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at completion of radiotherapy and then every 2 months for 1 year
Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 332 patients 166 per treatment arm will be accrued for this study within 145 months
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 |
|---|---|---|---|
| U10CA021661 | NIH | None | httpsreporternihgovquickSearchU10CA021661 |
| RTOG-BR-0118 | None | None | None |
| CDR0000069268 | None | None | None |