Groupe d'Etude en Oncologie du Quebec

Titre	An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
Protocole ID	MOUNTAINEER-03
ClinicalTrials.gov ID	NCT05253651
Type(s) de cancer	Côlon et rectum
Phase	Phase III
Stade	Métastatique
Type étude	Clinique
Médicament	Tucatinib en association avec trastuzumab et mFOLFOX6 versus mFOLFOX6 avec ou sans cétuximab ou bévacizumab
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville	Montréal
Investigateur(trice) principal(e)	Dr Petr Kavan
Coordonnateur(trice)	Oleg Lapsin 514-340-8222 poste 28437
Statut	Actif en recrutement
Date d'activation	23-01-2023
Critètes d'éligibilité
Critètes d'exclusion	Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery) Previous treatment with anti-HER2 therapy Ongoing Grade 3 or higher neuropathy GI perforation within 12 months of enrollment

Groupe d'étude en oncologie du Québec