Status:
COMPLETED
Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
LEO Pharma
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The blood thinner "tinzaparin" might increase survival in patients with colon cancer undergoing surgical resection. The investigators want to assess if a trial allocating patients to prolonged treatme...
Detailed Description
Cancer patients are at high risk of postoperative thrombosis and this risk remains elevated beyond the period of hospitalization. Thromboprophylaxis effectively reduces the risk of post operative VTE ...
Eligibility Criteria
Inclusion
- Males or females aged 18 years or older with a pathologically confirmed localized invasive colorectal cancer and no evidence of metastatic disease who are scheduled to undergo surgical resection will be eligible.
- All study patients must be enrolled at least two weeks prior to scheduled surgery and provide written informed consent.
- All the following criteria must be met to be eligible:
- Pathological confirmation of an invasive adenocarcinoma of the colon;
- No evidence of metastatic disease by Computed Tomography (CT) scan of the abdomen and pelvis or chest X-ray (CXR). A Magnetic Resonance Imaging (MRI) of the abdomen and pelvis will be used if the patient has a documented contrast allergy or to verify a questionable finding on the CT scan. Any abnormal findings on CXR will be investigated with a CT scan of the chest. Imaging must be performed within 2 months of randomization;
- a scheduled surgical operation for resection of the colon cancer; and
- ECOG performance status 0 or 1.
Exclusion
- Subjects cannot be included in this study if any of the following criteria apply:
- rectal adenocarcinoma (defined as tumor below the peritoneal reflection or within 12 cm of the anal verge by rigid sigmoidoscopy);
- prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE);
- requirement for full dose perioperative anticoagulation;
- requirement for anti-platelet or anti-inflammatory therapy that cannot be discontinued;
- contraindication to heparin therapy \*\*;
- 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 PI);
- \< 18 years of age;
- 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; and
- unable/unwilling to providing informed consent.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00967148
Start Date
June 1 2009
End Date
September 1 2010
Last Update
October 22 2014
Active Locations (1)
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1
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1H 8L6