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.
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
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.
- Conditions
- Colorectal Adenocarcinoma, Hepatic Metastases
- 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.
Progression free survival (PFS) and/or hepatic progression free survival
Measured: 3 years after inclusion
Secondary outcomes (2)
Overall survival (OS)
Measured: 3 years after inclusion
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.
- First posted11 Dec 2017
- Study start3 Feb 2016
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Practice of Debiri in France: Indications, Associations to Systemic Treatments, Efficiency, Tolerance - Prospective Practice Survey
- ClinicalTrials.gov ID
- NCT03369041
- Acronym / sponsor ID
- DEBIRI Cohort
- Conditions
- Colorectal Adenocarcinoma, Hepatic Metastases
- Keywords
- chemoembolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who started treatment with DEBIRI before 2015
- Patients who for psychological, social, family or geographic reasons could not be monitored regularly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan-Eluting BeadsAlso: DEBIRI | Drug | – |
Primary outcome
Progression free survival (PFS) and/or hepatic progression free survival
Time frame: 3 years after inclusion
2 secondary outcomes
Overall survival (OS)
Time frame: 3 years after inclusion
Best response rate
Time frame: 6 months after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
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.