NCT01721954

FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Sirtex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	FOLFOX6m
DEVICE	SIR-Spheres microspheres

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-23
• Completion: 2017-02-28
• First posted: 2012-11-06
• Last updated: 2019-11-05
• Results posted: 2019-10-22

Locations

83 sites across 13 countries: United States, Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, Singapore, South Korea, Spain, Taiwan