TITRE Étude de phase II pour évaluer l’innocuité de la prise en charge non chirurgicale du cancer du bas rectum
PROTOCOLE ID PJT - 148730 (NOM - rectal cancer)
CLINICAL TRIAL.gov ID NCT03179540
TYPE(S) DE CANCER Colorectal
PHASE Phase II
TYPE D'ÉTUDE
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Sébastien Drolet
COORDONATEUR(RICE) Nicole Chabot
nicole.chabot@crchudequebec.ulaval.ca
418-525-4444 poste 53266
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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
CRITÈRES D'EXCLUSION (EN)
  • 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