- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967148
Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer (PERI-OP)
October 21, 2014 updated by: Ottawa Hospital Research Institute
The Use of Extended Perioperative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 in cancer patients.
Extended thromboprophylaxis beyond hospitalization (up to 30 days) with LMWH has been shown to further reduce the risk of postoperative VTE.
Concurrently, there is a growing body of evidence to suggest that LMWH may have anti-cancer effects due to anti-metastatic properties and may improve survival in cancer patients, even in the absence of a documented VTE.
Retrospective studies have shown that perioperative thromboprophylaxis (i.e., starting thromboprophylaxis before the surgery) seems to increase survival in cancer patients undergoing abdominal or pelvic cancer surgery with curative intent.
The investigators propose to perform an open-label RCT to determine if thromboprophylaxis using tinzaparin 4,500 IU daily, starting from the time of decision to operate through the peri-operative period and extending for 4 weeks postoperatively, is feasible.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Health Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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 Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tinzaparin
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.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Standard of care
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recruitment rate
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Refusal rate
Time Frame: 3 months
|
3 months
|
Rate of non-compliance and lost to follow-up
Time Frame: 6 months
|
6 months
|
Expression of sialylated fucosylated glycans (including CA19-9, sialyl Lewis X and CD24) in primary tumor specimens by immunohistochemistry (IHC).
Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4
|
postoperative day 0, 1, 4, 7±1, and 28±4
|
Expression of TF. VEGF and microvessel density in primary tumor specimens by IHC.
Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4
|
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).
Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4
|
postoperative day 0, 1, 4, 7±1, and 28±4
|
Platelet count and serum soluble P-selectin levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by hemocytometer and ELISA.
Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4
|
postoperative day 0, 1, 4, 7±1, and 28±4
|
Serum VEGF levels pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by ELISA
Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4
|
postoperative day 0, 1, 4, 7±1, and 28±4
|
Quantification and characterization of VPC pre and postoperatively (postoperative day 0, 1, 4, 7±1, and 28±4) measured by VPC cell culture assay and flow cytometry.
Time Frame: postoperative day 0, 1, 4, 7±1, and 28±4
|
postoperative day 0, 1, 4, 7±1, and 28±4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marc Carrier, MD MSc, Ottawa Hospital Research Institute
- Principal Investigator: Rebecca Auer, MD MSc, Ottawa Hospital Research Institute
- Study Chair: Tim Asmis, MD, Ottawa Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
July 8, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (ESTIMATE)
August 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 22, 2014
Last Update Submitted That Met QC Criteria
October 21, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Pulmonary Embolism
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- 2009121-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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