Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer
Protocole ID	GRECO-2
ClinicalTrials.gov ID	NCT04698915
Type(s) de cancer	Pancréas
Phase	Phase II
Type étude	Clinique
Médicament	GC4711 en association avec la radiothérapie stéréotaxique corporelle
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 Tamim Niazi
Coordonnateur(trice)	Rokaya Elmisri 514-340-8222 poste 26510
Statut	Actif en recrutement
Critètes d'éligibilité	Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT Remain non-metastatic as confirmed by a CT scan at screening. Female or male subjects ≥ 18 years of age ECOG performance status of 0-2 Adequate end-organ function
Critètes d'exclusion	Subjects with documented metastatic disease First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen Prior abdominal RT with substantial overlap in radiation fields Subjects not recovered/controlled from treatment-related toxicities Uncontrolled malignancy other than PC Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy

Groupe d'étude en oncologie du Québec