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Colorectal AdenocarcinomaNCT03369041

Study of the Practice of Debiri in France

An observational study of Colorectal Adenocarcinoma and Hepatic Metastases, run by Federation Francophone de Cancerologie Digestive at 16 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Colorectal Adenocarcinoma, Hepatic Metastases
What is being tested?
Irinotecan-Eluting Beads
How many people
70 participants
Where
16 sitesFrance
Study dates
3 Feb 2016to 15 Oct 2022
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites
  • Centre Hospitalier de Blois

    Blois

  • Avicenne

    Bobigny

  • CHU Estaing

    Clermont-Ferrand

  • Clinique des Cèdres

    Cornebarrieu

  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf

    Elbeuf

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble

  • CHU de Grenoble

    Grenoble

  • Centre Léon Berard

    Lyon

  • Hôpital Privé Jean Mermoz

    Lyon

  • Hôpital Le Raincy Montfermeil

    Montfermeil

  • Centre Antoine Lacassagne

    Nice

  • Hôpital Européen Georges Pompidou

    Paris

  • CHU Lyon Sud

    Pierre-Bénite

  • Hôpital de la Miletrie

    Poitiers

  • CH

    Reims

  • HIA Begin

    Saint-Mandé

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Irinotecan-Eluting Beads
Keywords
chemoembolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan-Eluting BeadsDrug

    Also called DEBIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) and/or hepatic progression free survival

    Measured: 3 years after inclusion

Secondary outcomes (2)
  1. Overall survival (OS)

    Measured: 3 years after inclusion

  2. Best response rate

    Measured: 6 months after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start3 Feb 2016
  3. Primary completion15 Oct 2022 (estimated)
  4. Study completion15 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03369041
Sponsor's protocol ID
DEBIRI Cohort
Status last verified
Aug 2022
First submitted
13 Jul 2017
Last updated
19 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Adenocarcinoma and Hepatic Metastases, run by Federation Francophone de Cancerologie Digestive at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) and/or hepatic progression free survival (time frame: 3 years after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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