Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
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.
|Metastatic Cancer||Drug: efaproxiral Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
|Study Start Date:||February 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005887
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|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|