Titre 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
Type(s) de cancer Colorectal
Phase Phase II
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL SAINT-FRANCOIS D'ASSISE
      10 Rue de l'Espinay, Québec, QC, G1L 3L5
Ville Québec
Investigateur(trice) principal(e) Dr Sébastien Drolet
Coordonnateur(trice)
Statut Actif en recrutement
Critètes d'éligibilité
  • 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
Critètes d'exclusion
  • 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