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Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study

NCT01839877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-10-08

Study results available
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Summary

Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy.

Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic.

Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers.

The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.

Conditions

  • Colorectal Cancer With Non Resectable Hepatic Metastasis

Interventions

DRUG

HIA DEBIRI + systemic FOLFOX

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • Julien TAIEB, Pr · Fédération Francophone de Cancérologie Digestive

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-12-31
Completion
2019-01-31

Countries

  • France

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 NCT01839877 on ClinicalTrials.gov