Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
NCT ID: NCT07124858
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2026-03-01
2031-12-31
Brief Summary
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Detailed Description
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Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters.
The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib.
As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Fruquintinib
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.
Fruquintinib
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.
Interventions
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Fruquintinib
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
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Locations
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Poitiers CHU
Poitiers, France, 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
Countries
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Facility Contacts
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Other Identifiers
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2024-A00994-43
Identifier Type: REGISTRY
Identifier Source: secondary_id
COFRUQ COHORT
Identifier Type: -
Identifier Source: org_study_id
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