Titre Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach
Protocole ID 14-407 GEN
ClinicalTrials.gov ID NCT03001362
Type(s) de cancer Anus
Phase Phase II
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   SITE GLEN
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dr Neil Kopek
Coordonnateur(trice) Tatiana Carvalho
514-934-1934 poste 43698
Statut Actif en recrutement
Critètes d'éligibilité
  • Pelvic MRI defined disease (at least one of the following):
  • mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4)
  • involvement of muscularis propria (T2)
  • extra-mural vascular invasion
  • tumour deposit within the mesorectum
  • one or more involved mesorectal lymph node
  • Patients are considered medically fit for oncologic resection
  • ECOG performance status 0 or 1
  • No evidence of established metastatic disease (CT chest and abdomen)
  • Absolute neutrophil count >1.5x109/L; platelets >100x109/L,
  • Serum transaminase <3 x ULN;
  • Adequate renal function (Cockroft Gault estimation >50 mL/min)
  • Bilirubin <1.5 x ULN
  • Ability to comply with oral medication
  • Willingness and ability to give informed consent and comply with treatment and follow up schedule
  • Age 18 or over
Critètes d'exclusion
  • Previous radiotherapy to the pelvis (including brachytherapy)
  • Enlarged extramesorectal nodes
  • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
  • T1N0 disease without extra-mural venous invasion
  • Unequivocal evidence of metastatic disease (includes resectable metastases)
  • Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
  • History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
  • Known dihydropyrimidine dehydrogenase deficiency
  • Known Gilberts disease (hyperbilirubinaemia)
  • Taking warfarin or phenytoin or sorivudine
  • Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
  • Pregnant, lactating, or pre-menopausal women not using adequate contraception
  • Unfit to receive any study treatment or subsequent surgical resection