Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005887
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2000-06-02
Brief Title:
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase III Randomized Open-Label Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
Status:
COMPLETED
Status Verified Date:
2021-08
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 Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases
Detailed Description:
OBJECTIVES
Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13
Compare the response rate to these treatment regimens in these patients
Compare the time to progression after receiving these treatment regimens in these patients
Compare quality of life in these patients receiving these treatment regimens
Compare cause of death neurologic vs nonneurologic death in these patients after receiving these treatment regimens
Determine the safety of RSR13 in these patients
Assess the pharmacokinetics of RSR13 in these patients
OUTLINE This is a randomized open label comparative multicenter study Patients are stratified according to the Radiation Therapy Oncology Group RPA Class I vs II Patients are further stratified within the RPA class II stratum according to site of primary cancer non-small cell lung cancer vs breast vs other Patients are randomized to one of two treatment arms
Arm I Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing
Arm II Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I
Quality of life is assessed at the first and last day of radiotherapy at 1 month 3 months and then every 3 months until disease progression
Patients are followed at 1 month 3 months every 3 months until disease progression and then for survival
PROJECTED ACCRUAL A maximum of 408 204 per treatment arm patients will be accrued for this study
Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13
Compare the response rate to these treatment regimens in these patients
Compare the time to progression after receiving these treatment regimens in these patients
Compare quality of life in these patients receiving these treatment regimens
Compare cause of death neurologic vs nonneurologic death in these patients after receiving these treatment regimens
Determine the safety of RSR13 in these patients
Assess the pharmacokinetics of RSR13 in these patients
OUTLINE This is a randomized open label comparative multicenter study Patients are stratified according to the Radiation Therapy Oncology Group RPA Class I vs II Patients are further stratified within the RPA class II stratum according to site of primary cancer non-small cell lung cancer vs breast vs other Patients are randomized to one of two treatment arms
Arm I Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing
Arm II Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I
Quality of life is assessed at the first and last day of radiotherapy at 1 month 3 months and then every 3 months until disease progression
Patients are followed at 1 month 3 months every 3 months until disease progression and then for survival
PROJECTED ACCRUAL A maximum of 408 204 per treatment arm patients will be accrued for this study
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 |
|---|---|---|---|
| ALLOS-RSR13RT-009 | None | None | None |