Colorectal

TITRE	Meilleure préservation d’organe : Proposition d’étude multicentrique (Morpheus) comparant la curiethérapie à haut débit de dose à la radiothérapie externe guidée par l’image – Une étude de phase III à répartition aléatoire
PROTOCOLE ID	Morpheus study (no surgery)
CLINICAL TRIAL.gov ID	NCT03051464
TYPE(S) DE CANCER	Colorectal
PHASE
TYPE D'ÉTUDE	Clinique
INSTITUTION	CHUM 1051 rue Sanguinet (514) 890-8000
VILLE	Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E)	Carole Richard
COORDONATEUR(RICE)	Nassima Taleb nassima.taleb.chum@ssss.gouv.qc.ca 514-890-8000 poste 10812
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound Rectal cancer staged as N0-N1 by MRI or EUS/TRUS No metastatic lesion Rectal tumor occupying less than half of the circumference Tumor less than 5 cm on its largest dimension Tumor located at less than 10 cm from the anal verge Tumor penetration less than 5 mm in the mesorectal fat Tumor accessible for brachytherapy Lumen accessible for colonoscopy Patient should be a suitable candidate for brachytherapy and chemotherapy Older than 18 years of age Adequate birth control measures in women of childbearing potential Written informed consent
CRITÈRES D'EXCLUSION	(EN) Patients with previous pelvic radiation Evidence of distant metastasis Extension of malignant disease to the anal canal Tumors staged as T4 Tumors larger than 5 cm in length