CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 209 enrolled
Drug / intervention
FOLFOX6m +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01721954
NCT01721954Phase 3Completed

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

Sirtex Medical·interventional·Posted Nov 6, 2012·Updated Nov 5, 2019

In Brief

A Phase 3 clinical trial evaluating FOLFOX6m and SIR-Spheres microspheres for Colorectal Cancer Metastatic. Completed, enrolled 209 participants across 83 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, Singapore, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2012
Enrollment StartMay 1, 2013
Primary CompletionDec 23, 2016
Study CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.7 years ago

Interventions

FOLFOX6mdrug

SIR-Spheres microspheresdevice