Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme

PHASE2RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

January 20, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

January 31, 2030

Conditions
Digestive CancerColorectal Cancer
Interventions
DRUG

FOLFOX regimen

Oxaliplatin will be administered at a fixed dose of 85 mg/m² by 2h intravenous (IV) infusion concurrently with folinic acid 400 mg/m² (or 200 mg/m² if L-folinic acid) as a 2 h IV infusion on day 1 of each 14-day cycle followed by 5-fluorouracil (5-FU) 400 mg/m² IV bolus on day 1, then continuous IV infusion of 1,200 mg/m² /day × 2 days (total 2400 mg/m² for 46-48 hours)

DRUG

CAPOX regimen

Oxaliplatin will be administered at a fixed dose of 130 mg/m² by 2h IV infusion on day 1 of each 21-day cycle followed by capecitabine (1000 mg/m²) twice a day (BID) during 2 weeks, every 3 weeks

Trial Locations (34)

14000

NOT_YET_RECRUITING

Centre François Baclesse, Caen

NOT_YET_RECRUITING

Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana, Caen

14400

NOT_YET_RECRUITING

CH Aunay Bayeux, Bayeux

21079

NOT_YET_RECRUITING

CHU Dijon, Dijon

25000

NOT_YET_RECRUITING

CHU Besançon, Besançon

25200

NOT_YET_RECRUITING

Hopital Nord Franche Comté - Site du Mittan, Montbéliard

31059

NOT_YET_RECRUITING

CHU de Toulouse, Toulouse

33600

NOT_YET_RECRUITING

CHU Bordeaux, Pessac

35403

NOT_YET_RECRUITING

CH de Saint Malo, St-Malo

37044

NOT_YET_RECRUITING

Hopital Bretonneau, Tours

38028

NOT_YET_RECRUITING

GH Mutualiste de Grenoble, Grenoble

45067

NOT_YET_RECRUITING

CHU d'Orléans, Orléans

50054

NOT_YET_RECRUITING

CHU Amiens, Amiens

51100

NOT_YET_RECRUITING

Hopital Robert Debré, Reims

NOT_YET_RECRUITING

Institut Jean Godinot, Reims

63003

NOT_YET_RECRUITING

CHU Clermont Ferrand, Clermont-Ferrand

64109

NOT_YET_RECRUITING

CH Cote Basque, Bayonne

67033

NOT_YET_RECRUITING

Institut du Cancer de Strasbourg, Strasbourg

69008

NOT_YET_RECRUITING

Hopital Privé Jean Mermoz, Lyon

69373

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

69495

NOT_YET_RECRUITING

Hospices Civiles de Lyon, Pierre-Bénite

75005

NOT_YET_RECRUITING

Institut Curie, Paris

75010

NOT_YET_RECRUITING

Hopital Saint Louis, Paris

75012

NOT_YET_RECRUITING

Hopital Saint Antoine, Paris

75020

NOT_YET_RECRUITING

GH Diaconesses Croix St Simon, Paris

77100

NOT_YET_RECRUITING

Grand Hopital de l'Est Francilien, Meaux

84000

NOT_YET_RECRUITING

Institut du Cancer Avignon Provence, Avignon

86000

NOT_YET_RECRUITING

CHU Poitiers, Poitiers

87042

NOT_YET_RECRUITING

CHU Dupuytren, Limoges

92110

NOT_YET_RECRUITING

Hopital Beaujon, Clichy

94010

NOT_YET_RECRUITING

Hopital Henri Mondor, Créteil

94805

RECRUITING

Gustave Roussy Cancer Campus, Villejuif

07500

NOT_YET_RECRUITING

Hopital Privé Drome-Ardeche, Guilherand-Granges

06189

NOT_YET_RECRUITING

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

UNICANCER

OTHER