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

NCT01721954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2019-11-05

Study results available
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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

DRUG

FOLFOX6m

DEVICE

SIR-Spheres microspheres

Sponsors & Collaborators

  • Sirtex Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-01
Primary Completion
2016-12-23
Completion
2017-02-28

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Israel
  • Italy
  • New Zealand
  • Portugal
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721954 on ClinicalTrials.gov