Study of the Practice of Debiri in France

Study of the Practice of Debiri in France: Indications, Associations to Systemic Treatments, Efficiency, Tolerance - Prospective Practice Survey

In order to extract the profiles of patients receiving DEBIRI treatment at best, the investigators proposed the establishment of a national prospective cohort to collect information on the greatest number of patients treated with DEBIRI. This cohort will allow a better understanding of the effectiveness, tolerance, feasibility and differences of practices at national level for this approach. These data will assist in the development of clinical trials in situations that appear to be most promising in clinical practice.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Adenocarcinoma; Hepatic Metastases
• Intervention / Treatment: Drug: Irinotecan-Eluting Beads

Detailed Description

Colorectal cancer (CRC) is the third most common cancer in men and the second in women (1.23 million cases in 2008, 608700 deaths) 40 to 50% of patients developed hepatic, synchronous or metachronous metastases. In 10 to 15% of cases, these metastases are operable initially, and a perioperative chemotherapy of the FOLFOX type is then most performed. In about 20% of patients discharged metastases resectable after induction chemotherapy. When hepatic invasion makes a complete resection impossible, a palliative treatment is initiated, mainly based on chemotherapy with or without biotherapies (anti-VEGF or anti-EGFR).

In recent years, intra-hepatic arterial treatments have been developed, with the aim of improving the prognosis of inoperable patients. The particular vascular anatomy of the liver makes it possible to perform local work via its main artery or its branches. The hepatic artery provides 25% of the blood flow and 50% of the oxygenation of the liver, the portal vein ensures 75% of the blood flow and also 50% of the oxygenation. Primary or secondary tumors are mainly focused on the artery and the rest of the parenchyma mainly through the portal vein, treatment of tumors using the arterial route also allows to administer under satisfactory safety conditions the therapeutic agent of Many More selective within the tumor, saves healthy hepatic tissue.

Several approaches to intra-arterial treatments have been developed to date, such as hepatic intra-arterial chemotherapy, radioembolization, or micro-bead embolization (DC-Beads®). In the latter case, they are DEB Drug Eluting Beads at irinotecan, in the context of a treatment called DEBIRI. Thanks to their diameter of 75 to 300 μm, they allow embolization of the tumor's arterioles, with a dual objective: to create tumor ischemia and increase the intra-tumor concentration in chemotherapy. The advantage of this approach is simplicity. Contrary to the two previous techniques (radio and chemo-embolization), it does not require the placement of an intra-arterial catheter, nor the administration of a radioactive agent imposing heavy use constraints. It could make this intra-arterial technique accessible in many centers and thus benefit a greater number of patients.

Data on the use of this strategy remain limited, and concern patients already treated by several lines of chemotherapy. The response rates in these heavily pretreated patients are encouraging.

Several questions arise: firstly, what is the place of this treatment used so far in patients treated with the treatises (2 tests currently published). In practice, few patients have limited liver disease after 2 or 3 lines of chemotherapy, which reserves this approach for a small minority of patients. It should be tried to develop this technique earlier in the cost of patients, in order to propose, for example, as a consolidation treatment in patients who are not resectable or to try to have a down-sizing in potentially resectable patients. Response rate of 65% in pretreated patients.

Other questions remain unanswered about this therapeutic approach: should systemic treatment with 5FU be used to reduce the risk of extrahepatic progression? Is it possible, and can the investigators associate, systemic chemotherapy such as oxaliplatin to intensify the response? And finally, what is the place of biotherapies in this strategy? None of the questions have been discussed with DEBIRI to date.

In order to extract the profiles of patients receiving DEBIRI treatment at best, the investigators propose the establishment of a national prospective cohort to collect information on the greatest number of patients treated with DEBIRI. This cohort has allowed a better understanding of the effectiveness, tolerance, feasibility and differences of practices at national level for this approach. These data will assist in the development of clinical trials in situations that appear to be most promising in clinical practice.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Blois, France
    • Centre Hospitalier de Blois
  • Bobigny, France
    • Avicenne
  • Clermont-Ferrand, France
    • CHU Estaing
  • Cornebarrieu, France
    • Clinique des Cèdres
  • Elbeuf, France
    • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
  • Grenoble, France
    • Chu de Grenoble
  • Grenoble, France
    • CHU de Grenoble - Hopital de la Tronche
  • Lyon, France
    • Centre Léon Bérard
  • Lyon, France
    • Hopital Prive Jean Mermoz
  • Montfermeil, France
    • Hôpital Le Raincy Montfermeil
  • Nice, France
    • Centre Antoine Lacassagne
  • Paris, France
    • Hopital Europeen Georges Pompidou
  • Pierre-Bénite, France
    • CHU Lyon Sud
  • Poitiers, France
    • Hôpital de la Milétrie
  • Reims, France
    • CH
  • Saint Mande, France
    • Hia Begin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with histologically proven colorectal adenocarcinoma and synchronous or metachronous hepatic metastases with indication of treatment by DEBIRI retained after 2015.

Description

Inclusion Criteria:

• Patients aged 18 years and over
• Histologically proven colorectal adenocarcinoma
• Synchronous or metachronous hepatic metastases
• No significant extrahepatic disease
• Indication of treatment by DEBIRI retained
• Patient who received the information note

Exclusion Criteria:

• Patients who started treatment with DEBIRI before 2015
• Patients who for psychological, social, family or geographic reasons could not be monitored regularly.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS) and/or hepatic progression free survival	3 years after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	3 years after inclusion
Best response rate	6 months after the end of treatment

Collaborators and Investigators

• Sponsor: Federation Francophone de Cancerologie Digestive

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2016
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: chemoembolization
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: DEBIRI Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No