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

December 21, 2020 updated by: Federation Francophone de Cancerologie Digestive

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • Hôpital Saint André
      • Dijon, France
        • CHU - Hôpital François Mitterand
      • Lyon, France, 69373
        • Centre Leon Bérard
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13273
        • Institut Paoli Calmette
      • Paris, France, 75015
        • Hopital Europeen G Pompidou
      • Rouen, France, 76031
        • Chu Charles Nicolle
      • Toulouse, France, 31059
        • Hopital Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven colorectal adenocarcinoma,
  • Liver metastases radiologically or histologically proven
  • At least one measurable liver lesions by RECIST v1.1
  • Age ≥ 18 years
  • WHO Index < or = 2
  • Life expectancy ≥ 3 months
  • No extrahepatic disease except lung nodules if number < or = 3 and size < 10 mm each
  • Healthy liver <60%
  • Primary tumor resected or still in place
  • No prior chemotherapy for metastases treatment (except a perioperative chemotherapy, if the last cycle was administered at least 12 months ago)
  • Adjuvant chemotherapy after resection of the primary authorized if the last cycle was administered at least 12 months ago
  • Normal hepatic function: total bilirubin ≤ 1.5 N; AST ≤ 5N; ALT ≤ 5N and PAL ≤ 5N
  • TP ≥ 60%
  • Adequate hematologic function: ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hb ≥ 9g/dl
  • Good renal function: creatinine clearance ≥ 60 mL / min
  • No cardiac dysfunction: no cardiovascular events in the last 6 months or no NYHA ≥ 2

Exclusion Criteria:

  • Patient eligible for curative treatment (resection and / or radiofrequency ablation) by a multidisciplinary decision (including the opinion of a liver surgeon)
  • Pregnant or lactating woman or patients of both sexes and of childbearing age not using adequate contraception
  • History of cancer, except skin cancer (other than melanoma), carcinoma in situ of the cervix uteri treated curative. Other cancers treated with curative intent are permitted provided they did not relapse over the last 5 years
  • Peripheral neuropathy
  • Inflammatory Bowel Diseases
  • Intestinal obstruction
  • Chronic liver disease (viral, alcoholic or metabolic)
  • Immune Deficiency Syndromes (history of transplantation, infection with HIV)
  • Known to have contraindications to 5FU, oxaliplatin, folinic acid, irinotecan or to contrast products
  • Patients with known contraindications against hepatic embolization procedures:

Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of the portal vein

  • Patient who for psychological, social, family or geographical reasons could not be followed up regularly
  • Legal disability (persons deprived of liberty or under guardianship)
  • Patient is not affiliated to a social security scheme
  • Participation in another concurrent study investigating the effect of treatment and this until 4 weeks after the end of the concurrent study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIA DEBIRI + systemic FOLFOX
Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX
Drug: HIA DEBIRI + systemic FOLFOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival rate at 9 months
Time Frame: at 9 months after inclusion
at 9 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of the study treatment
Time Frame: at 9 months after inclusion
Adverse event rate; all grade, grades 1-2 and grades 3-4
at 9 months after inclusion
Overall survival
Time Frame: 2 years after last patient in
2 years after last patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Collaborators

Biocompatibles UK Ltd

Investigators

  • Principal Investigator: Julien TAIEB, Pr, Federation Francophone de Cancerologie Digestive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFCD 1201 DEBIRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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