FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.
Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
Colorectal Cancer Metastatic
Device: SIR-Spheres microspheres
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study|
- Overall Survival [ Time Frame: Time of randomization for an average of two years. ] [ Designated as safety issue: No ]To compare the effectiveness of treatment with SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone in terms of overall survival.
- Progression Free Survival [ Time Frame: Date of randomization for an average of 12 months. ] [ Designated as safety issue: No ]To compare the effectiveness of SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Control Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Experimental: Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
|Drug: FOLFOX6m Device: SIR-Spheres microspheres|