Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer

NCT00967148 | Completed DMC

• 1 other identifier: 2009121-01H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 treatment with tinzaparin versus standard of care is feasible.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism; Cancer

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  3 months

Secondary Outcomes (8)

• Refusal rate

  3 months

• Rate of non-compliance and lost to follow-up

  6 months

• Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC).

  postoperative day 0, 1, 4, 7±1, and 28±4

• Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC.

  postoperative day 0, 1, 4, 7±1, and 28±4

• Serum soluble TF and TFPI levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by enzyme linked immunosorbent assay (ELISA).

  postoperative day 0, 1, 4, 7±1, and 28±4

Study Arms (2)

Tinzaparin

EXPERIMENTAL

The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.

Drug: Tinzaparin

Standard of care

ACTIVE COMPARATOR

The control arm will receive a subcutaneous injection of 4,500 U of tinzaparin daily beginning with the first postoperative dose and continued for the duration of hospitalization.

Drug: Tinzaparin

Interventions

Tinzaparin DRUG

The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.

Also known as: Innohep

Standard of care; Tinzaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• LEO Pharma: collaborator

Study Sites (1)

Ottawa Health Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Neoplasms

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Marc Carrier, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Rebecca Auer, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Tim Asmis, MD

  Ottawa Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: August 27, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

CA (1)