mFOLFOX6 + SIRT for Colorectal Cancer (SIRFLOX Trial)

N/A

Waitlist Available

Led By Peter Gibbs, MD

Research Sponsored by Sirtex Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma. 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 treating Investigator.

Eligible Conditions

Liver Metastases
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) at Any Site

Secondary study objectives

Percentage of Participants With Overall Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mFOLFOX6 + SIRTExperimental Treatment1 Intervention

A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)

Group II: mFOLFOX6Active Control1 Intervention

Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SIR-Spheres yttrium-90 microspheres

2006

N/A

~530

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