Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
COFRUQ
PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
2 other identifiers
interventional
300
1 country
83
Brief Summary
The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedStudy Start
First participant enrolled
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
May 26, 2026
May 1, 2026
5 years
August 8, 2025
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
OS is defined as the time interval (months) between the date of initiation of treatment with fruquintinib and the date of death (from any cause).
up to 1 year after treatment start
Secondary Outcomes (1)
progression free survival
up to 1 year after treatment start
Study Arms (1)
Fruquintinib
OTHERFruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.
Interventions
Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.
Eligibility Criteria
You may qualify if:
- Patients aged 18 and over.
- Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
- Obtain informed consent from the patient for the clinical-biological cohort.
- Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).
You may not qualify if:
- Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
- Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
- Pregnant or breast-feeding women.
- Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Poitiers CHU
Poitiers, France, 86021, France
Centre Hospitalier
Albi, France
CHU
Amiens, France
Clinique de L Europe
Amiens, France
Centre Hospitalier
Annecy, France
Centre Hospitalier
Aurillac, France
Centre Hospitalier
Bayeux, France
Centre Hospitalier
Bayonne, France
Centre Hospitalier
Beauvais, France
CHU
Besançon, France
Centre Hospitalier Bethune Beuvry
Beuvry, France
Centre Pierre Curie
Beuvry, France
Clinique Tivoli
Bordeaux, France
Polynclinique Bordeaux Nord Aquitaine
Bordeaux, France
CHU
Brest, France
CHU
Caen, France
Centre Hospitalier
Calais, France
Infirmerie Protestante
Caluire-et-Cuire, France
Clinique Sainte Marie
Chalon-sur-Saône, France
ROC37
Chambray-lès-Tours, France
Centre Hospitalier
Chartres, France
Centre Hospitalier
Cholet, France
Clinique Sainte Come
Compiègne, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Clinique Branche - Clinique Flandres
Coudekerque-Branche, France
Centre Hospitalier Henri Mondor
Créteil, France
Centre Leonard de Vinci
Dechy, France
Chu Francois Mitterand
Dijon, France
Institut de Cancerologie de Bourgogne
Dijon, France
Hopital Prive Forcilles
Férolles-Attilly, France
Centre Hospitalier
Flers, France
CHI
Fréjus, France
Groupe Hospitalier Mutualiste
Grenoble, France
Polyclinique de Blois
La Chaussée-Saint-Victor, France
Clinique Sainte Clothilde
La Réunion, France
Centre Hospitalier de Vendee
La Roche-sur-Yon, France
Hopital Prive de L Estuaire
Le Havre, France
Centre Hospitalier
Le Puy-en-Velay, France
Centre Hospitalier
Lens, France
CHU
Lille, France
CHU
Limoges, France
Groupement Hospitalier Bretagne Sud
Lorient, France
Clinique Jean Mermoz
Lyon, France
Hopital Europeen
Marseille, France
Hopital Saint Joseph
Marseille, France
La Timone
Marseille, France
Clinique Gray
Maubeuge, France
Ch Du Mittan
Montbéliard, France
Institut de Cancerologie de Lorraine
Nancy, France
Hopital Prive Confluent
Nantes, France
Clinique Ambroise Pare Hartmann
Neuilly, France
Hopital Americain
Neuilly-sur-Seine, France
Centre Hospitalier
Niort, France
CH de la source
Orléans, France
BICHAT
Paris, France
COCHIN
Paris, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
Hopital Avicenne
Paris, France
Hopital Saint Louis
Paris, France
La Pitie Salepetriere
Paris, France
Saint Antoine
Paris, France
Centre Hospitalier
Pau, France
Hopital Instruction Des Armees
Percy, France
Centre Hospitalier
Perpignan, France
CHU
Pessac, France
Lyon Sud
Pierre-Bénite, France
Centre Cario
Plérin, France
CHU
Poitiers, France
CHU
Reims, France
CHU
Rennes, France
CHU
Rouen, France
Centre Hospitalier
Saint-Denis, France
Centre Hospitalier
Soissons, France
Centre Hospitalier
St-Malo, France
Clinique Sainte Anne
Strasbourg, France
Centre Hospitalier
Thonon-les-Bains, France
Chu Rangueil
Toulouse, France
CHU
Tours, France
Hopital Prive Drome Ardeche
Valence, France
CHU
Vandœuvre-lès-Nancy, France
Centre Hospitalier
Versailles, France
Hopital Nord Ouest
Villefranche-sur-Saône, France
Medipole Hopital Mutualiste
Villeurbanne, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2025
First Posted
August 15, 2025
Study Start
March 10, 2026
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
May 26, 2026
Record last verified: 2026-05