Titre A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer
Protocole ID PERIOP-01
ClinicalTrials.gov ID NCT01455831
Type(s) de cancer Côlon et rectum
Phase Phase III
Médicament Tinzaparin
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville Montréal
Investigateur(trice) principal(e) Dre Vicky Tagalakis
Coordonnateur(trice) Elena Shulikovsky
514-340-8222 poste 23703
Statut Actif en recrutement
Critètes d'éligibilité
  • Diagnosis of pathologically-confirmed invasive adenocarcinoma of the colon
  • Pre-operative work-up that reveals potential resectability (CT scan or MRI of the abdomen and pelvis within 90 days of randomization)
  • Pre-operative work-up that reveals no evidence of metastatic disease (CT scan or MRI of the abdomen and pelvis and chest X-ray (CXR) or CT scan of the chest within 90 days of randomization)
  • A planned surgical operation for resection of the colon cancer within 6 weeks from the date of randomization 
  • ECOG performance status 0 or 1
  • Age ≥18 years
  • Hemoglobin ≥ 80g/L
  • Able and willing to sign Research Ethics Board (REB)-approved written consent form
  • Able and willing to comply with study procedures and follow-up examinations contained within the written consent form.
Critètes d'exclusion
  • Rectal adenocarcinoma (defined as tumour below the peritoneal reflection on imaging or within 15 cm of the anal verge by rigid sigmoidoscopy)
  • Carcinoma only present in a completely excised polyp (i.e. no residual tumour evident in the colon)
  • Prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Requirement for full dose peri-operative anticoagulation
  • Contraindication to heparin therapy
  • history of heparin induced thrombocytopenia (HIT)
  • platelet count of less than 100 x 109/L
  • actively bleeding
  • severe hypertension (SBP >200 and/or DBP >120) on more than one reading
  • documented peptic ulcer within 6 weeks
  • severe hepatic failure (INR >1.8)
  • creatinine clearance of < 30 ml/min as calculated by the Cockcroft-Gault formula
  • heparin or pork allergy
  • Other contraindication to anticoagulation
  • Geographic inaccessibility (less likely to comply with required follow-up visits and care)
  • Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)
  • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years of the colorectal cancer diagnosis
  • Treatment, including radiation therapy, chemotherapy or targeted therapy, administered for the currently diagnosed colon cancer prior to randomization
  • Pregnant or lactating
  • Unable/unwilling to providing informed consent.