| 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
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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)
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A planned surgical operation for resection of the colon cancer within 6 weeks from the date of randomization
-
ECOG performance status 0 or 1
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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)
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Prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE)
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Requirement for full dose peri-operative anticoagulation
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Contraindication to heparin therapy
-
history of heparin induced thrombocytopenia (HIT)
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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
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heparin or pork allergy
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Other contraindication to anticoagulation
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Geographic inaccessibility (less likely to comply with required follow-up visits and care)
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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