Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 treatment with tinzaparin versus standard of care is feasible.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: LEO Pharma
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• 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:

1. Pathological confirmation of an invasive adenocarcinoma of the colon;

2. 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;

3. a scheduled surgical operation for resection of the colon cancer; and

4. ECOG performance status 0 or 1.

Exclusion Criteria:

• Subjects cannot be included in this study if any of the following criteria apply:

1. rectal adenocarcinoma (defined as tumor below the peritoneal reflection or within 12 cm of the anal verge by rigid sigmoidoscopy);

2. prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE);

3. requirement for full dose perioperative anticoagulation;

4. requirement for anti-platelet or anti-inflammatory therapy that cannot be discontinued;

5. contraindication to heparin therapy **;

6. geographic inaccessibility (less likely to comply with required follow-up visits and care);

7. participating in another interventional trial that may result in co-intervention or contamination (to be determined by PI);

8. < 18 years of age;

9. 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;

10. treatment, including radiation therapy, chemotherapy or targeted therapy, administered for the currently diagnosed colon cancer prior to randomization;

11. pregnant or lactating; and

12. unable/unwilling to providing informed consent.