Study of the Practice of Debiri in France
1 other identifier
observational
70
1 country
16
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2016
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2016
CompletedFirst Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedAugust 19, 2022
August 1, 2022
6.7 years
July 13, 2017
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) and/or hepatic progression free survival
3 years after inclusion
Secondary Outcomes (2)
Overall survival (OS)
3 years after inclusion
Best response rate
6 months after the end of treatment
Interventions
Eligibility Criteria
Patients with histologically proven colorectal adenocarcinoma and synchronous or metachronous hepatic metastases with indication of treatment by DEBIRI retained after 2015.
You may qualify if:
- 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
You may not qualify if:
- Patients who started treatment with DEBIRI before 2015
- Patients who for psychological, social, family or geographic reasons could not be monitored regularly.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Centre Hospitalier de Blois
Blois, France
Avicenne
Bobigny, France
CHU Estaing
Clermont-Ferrand, France
Clinique des Cèdres
Cornebarrieu, France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, France
CHU de Grenoble - Hopital de la Tronche
Grenoble, France
CHU de Grenoble
Grenoble, France
Centre Léon Berard
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
Hôpital Le Raincy Montfermeil
Montfermeil, France
Centre Antoine Lacassagne
Nice, France
Hôpital Européen Georges Pompidou
Paris, France
CHU Lyon Sud
Pierre-Bénite, France
Hôpital de la Miletrie
Poitiers, France
CH
Reims, France
HIA Begin
Saint-Mandé, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
December 11, 2017
Study Start
February 3, 2016
Primary Completion
October 15, 2022
Study Completion
October 15, 2022
Last Updated
August 19, 2022
Record last verified: 2022-08