Conditions: Colorectal Cancer Metastatic
Keywords: colon rectum metastatic colorectal cancer liver metastases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 209
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. arm 2: Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

Interventions: intervention 1: FOLFOX6m intervention 2: SIR-Spheres microspheres
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: