Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET
Protocole ID	SORENTO
ClinicalTrials.gov ID	NCT05050942
Type(s) de cancer	Tumeurs neuroendocrines
Phase	Phase III
Type étude	Clinique
Médicament	Octréotide dépôt sous cutanée (CAM2029) versus octréotide LAR ou Lanréotide ATG
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)	Aline Mamo 514-340-8222 poste 5525
Statut	Actif en recrutement
Date d'activation	10-05-2023
Critètes d'éligibilité	Male or female patient ≥18 years old Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization) ECOG performance status of 0 to 2
Critètes d'exclusion	Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease Known central nervous system metastases Consecutive treatment with long-acting SSAs for more than 6 months before randomization Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening Previously received radioligand therapy (PRRT) at any time

Groupe d'étude en oncologie du Québec