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
      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.