Status:
COMPLETED
Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Adenocarcinoma of the Colon
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The human body has a natural stress response to surgery, including the formation of blood clots. This response to surgery has been shown to increase metastases (the spread of cancer cells to other org...
Eligibility Criteria
Inclusion
- Diagnosis of pathologically-confirmed invasive adenocarcinoma of the colon or rectum
- Pre-operative work-up that reveals potential resectability (CT scan or MRI of the abdomen and pelvis) with resection planned within 6 weeks of date 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)
- Age ≥18 years
- Hemoglobin ≥ 80g/L
- Able and willing to comply with study procedures and follow-up examinations contained within the written consent form.
Exclusion
- 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
- Other contraindication to anticoagulation
- 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
- Pregnant or lactating
- Unable/unwilling to providing informed consent.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
616 Patients enrolled
Trial Details
Trial ID
NCT01455831
Start Date
September 1 2011
End Date
February 1 2021
Last Update
May 17 2021
Active Locations (16)
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1
Ghent University Hospital
Ghent, Belgium
2
Health Sciences North
Greater Sudbury, Ontario, Canada
3
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 8E7
4
Kingston General Hospital
Kingston, Ontario, Canada