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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01721954

Public ClinicalTrials.gov record NCT01721954. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01721954
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sirtex Medical
Industry
Enrollment
209 participants

Conditions and interventions

Interventions

Drug · Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 1, 2013 (Actual)
Primary completion
Dec 23, 2016 (Actual)
Completion
Feb 28, 2017 (Actual)
Last update posted
Nov 5, 2019

2013 – 2017

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
City of Hope Duarte California 91010 —
Orlando Health Orlando Florida 32806 —
Memorial Healthcare Pembroke Pines Florida 33028 —
University of Illinois Chicago Chicago Illinois 60607 —
Adventist Midwest Health Hinsdale Illinois 60521 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
University of Maryland Medical Center Baltimore Maryland 21201 —
Roswell Park Cancer Center Buffalo New York 14263 —
Lenox Hill Hospital New York New York 10075 —
Montefiore Medical Center The Bronx New York 10467 —
Carolinas Medical Center Charlotte North Carolina 28203 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213 —
Spartanburg Regional Healthcare / Gibbs Cancer Center Spartanburg South Carolina 29303 —
Methodist Hospital Dallas Dallas Texas 75203 —
St. Mark's Hospital Salt Lake City Utah 84124 —
Fletcher Allen Health Care Burlington Vermont 05405 —
West Virginia University Healthcare Morgantown West Virginia 26506 —
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01721954, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 5, 2019 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01721954 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →