| 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.
|
Groupe d'étude en oncologie du Québec