Groupe d'Etude en Oncologie du Quebec

Title	Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
Protocole ID	PJT - 148730 (NOM - rectal cancer)
ClinicalTrials.gov ID	NCT03179540
Cancer Type(s)	Colon and Rectum
Phase	Phase II
Stage
Study Type
Drug
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL SAINT-FRANCOIS D'ASSISE 10 Rue de l'Espinay, Québec, QC, G1L 3L5
City
Principal Investigator	Dr. Sébastien Drolet
Coordinator	Nicole Chabot 418-525-4444 poste 53266
Status	Recruiting
Activation Date
Eligibility Criteria	Completed chemoradiotherapy (CRT) as standard of care [Stage II and Stage III (T3-T4N0, AnyTN1-2)]; [50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine] Planned or probable APR ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT 18 years or older Provides written consent
Exclusion Criteria	Unable to undergo MRI Metastatic disease (including extramesorectal and retroperitoneal lymph nodes) Pregnancy Inflammatory bowel disease More than one primary colorectal cancer Other malignancy within 5 years of treatment for current rectal cancer Unfit for surgery

Groupe d'étude en oncologie du Québec