CancerPhase 3NCT00219973
CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)
A Phase 3 study testing Bemiparin in people with Cancer and Venous Thromboembolism, run by Rovi Pharmaceuticals Laboratories at 4 sites in 4 countries.
Trial summary
The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cancer, Venous Thromboembolism
- What is being tested?
- Bemiparin
- How many people
- 526 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 40 years of age or older, of either sex, who have given their informed consent to participate in the study.
- Patients with a malignant neoplastic process (primary or metastasic) of the gastrointestinal tract (except the oesophagus), genitourinary tract or female reproductive organs, previously diagnosed and documented, and who are programmed to undergo elective, open, curative or palliative surgery directly related to that disease.
- Patients undergoing surgery with general or spinal anaesthesia, with an estimated duration of surgery of over 30 minutes.
- Patients with a life expectancy of at least 3 months.
Who cannot join
- Curative or palliative surgery of a malignant neoplastic process in liver, biliary tract or pancreas.
- Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods.
- Patients with macrohaematuria, active haemorrhage within the past two months, organ lesions at risk of bleeding (e.g. active peptic ulcer, haemorrhagic cerebrovascular accident, aneurysms), a history of episodes of clinically evident haemorrhage, major surgery in the previous month or an increase in the risk of bleeding due to any disturbance of haemostasis which would contraindicate the anticoagulant therapy, with the exception of bleedings episodes directly caused by tumour subjected to the surgical intervention.
- Patients with known hypersensitivity to the LMWHs, to heparin or to substances of porcine origin.
- Patients with known hypersensitivity to radiological contrast media.
- Patients with known hypersensitivity to anaesthetic drugs or pre-anaesthetic drugs.
Show all 19Show fewer
- Patients with a congenital or acquired bleeding diathesis (confirmed by hematological test), with or without haematuria.
- Lesions or surgical interventions of the central nervous system, eyes or ears within the previous 6 months, including hemorrhagic or ischemic cerebro-vascular accident, cerebral thrombosis and/or known cerebral metastasis.
- Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.
- Acute bacterial endocarditis and slow endocarditis.
- Patients on treatment with oral or parenteral anticoagulants within 5 days before the operation.
- Patients with a history of thrombocytopenia associated with heparin or with a current platelet count <75,000/mm3.
- Patients with renal failure (defined as a serum creatinine over 2 mg/dL), hepatic insufficiency (with AST and/or ALT values > 5 times over normal values established by the reference range of the local laboratory of the hospital).
- Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
- One or more documented episodes of DVT and/or PE (confirmed by a ventilation-perfusion gamma scan or helical CT) in the previous 3 months.
- Patients with suspected or confirmed inability to comply with the study treatment and/or follow-up.
- Patients who are participating in another clinical trial or who have done so in the past 30 days.
- Patients with a cava vein filter in place.
- Patients needing the use of unallowed concomitant treatments or medications such as more than 125mg/day aspirin, NSAIDs with long half-life of significant anti-aggregation activity, metformin, or any anticoagulant compound (please refer to section of the protocol "Concomitant medications and treatments" for details)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Multicentric, Rand., D-b, Pbo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of the Thromboprophylaxis With Bemiparin 3,500 IU/d for 28 Days Compared to 8 Days, in Patients Undergoing Oncological Abdominal/ Pelvic Surgery
The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.
Read the detailed description
Although the efficacy of low-molecular-weight heparins(LMWH) in the prophylaxis of postoperative venous thromboembolism (VTE) is well established in a large number of studies, some aspects remain to be determined. The optimal duration of prophylactic treatment has not been clearly defined yet.
Traditionally, surgical prophylaxis of VTE in patients undergoing high-risk orthopaedic surgery was extended for one or two weeks after the operation. However, the most recent studies carried out on this field have demonstrated that prolongation of prophylaxis with LMWH for 4-6 weeks significantly reduces the incidence of VTE (by more than half) in patients undergoing orthopaedic surgery with a high-risk of VTE.
On the contrary, thromboprophylaxis in oncological surgery is generally limited to the period of hospitalisation, despite the fact that activation of coagulation is greater and more prolonged in patients undergoing surgery for neoplastic processes than in those patients not affected by cancer. The only two studies carried out to evaluate the efficacy of the prolongation of thromboprophylaxis for 4 weeks in this type of surgery seem to indicate that the VTE incidence could be reduced even further that with one-week prophylaxis, though these do not allow to establish a definitive conclusion.
The present study aims to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, giving the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.
Additionally, some exploratory analyses will be carried out to evaluate:
- The biological effect of the sc. administration of Bemiparin (3,500 IU/day) on different biological markers involved in the tumoral development and its metastasis in patients undergoing an oncological abdominal or pelvic surgical operation.
- The effect of the sc. administration of Bemiparin (3,500 IU/day) on the evolution of the tumour in patients undergoing an oncological abdominal or pelvic surgical operation.
- The effect of the sc. administration of Bemiparin (3,500 IU/day) on the survival of the patients at 6 months from the operation.
Four Study Committees have been created for this clinical trial in order to guarantee the safety of the patients as well as the highest quality data:
- Trial Steering Committee
- Data \& Safety Monitoring Board
- Committee for the Evaluation of Phlebographies
- Committee for Adjudicating Clinical Events.
- Conditions
- Cancer, Venous Thromboembolism
- Being tested
- Bemiparin
- Keywords
- venous thromboembolism, deep vein thrombosis, pulmonary embolism, bleeding, low-molecular-weight heparin, cancer, surgery
- Medical subject headings
- Neoplasms, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
Bemiparin 3.500 IU/day for 28 days compared to 8 days
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY: Combined incidence (from day 1 to day 20±2 after the randomisation): total DVT + non-fatal PE + all-cause mortality.
SAFETY: incidence of major bleeding (from day 1 to day 20±2 after the randomisation).
Secondary outcomes (3)
EFFICACY: combined and isolated incidence of DVT (Total, proximal and distal), non-fatal PE, deaths related and not related with VTE.
SAFETY: incidence of major bleeding (from day 1 to day 82±8 after the randomisation) and incidence of minor bleeding (from day 1 to day 20±2 and to day 82±8 after the randomisation).
EXPLORATORY ANALYSES: Biological markers, tumour evolution and survival at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vijay V Kakkar, Prof., Study director, Thrombosis Research Institute (London, UK)Paolo Prandoni, Prof., Study director, Faculty of Medicine, University of Padova (Padova, Italy)Jose Luis Balibrea-Cantero, Prof., Study director, Faculty of Medicine, Complutense University (Madrid, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219973
- Sponsor's protocol ID
- ROV-BEM-2003-02
- Status last verified
- Apr 2010
- First submitted
- 19 Sep 2005
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Rand., D-b, Pbo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of the Thromboprophylaxis With Bemiparin 3,500 IU/d for 28 Days Compared to 8 Days, in Patients Undergoing Oncological Abdominal/ Pelvic Surgery
- ClinicalTrials.gov ID
- NCT00219973
- Acronym / sponsor ID
- ROV-BEM-2003-02
- Conditions
- Cancer, Venous Thromboembolism
- Keywords
- venous thromboembolism, deep vein thrombosis, pulmonary embolism, bleeding, low-molecular-weight heparin, cancer, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.
Detailed description
Although the efficacy of low-molecular-weight heparins(LMWH) in the prophylaxis of postoperative venous thromboembolism (VTE) is well established in a large number of studies, some aspects remain to be determined. The optimal duration of prophylactic treatment has not been clearly defined yet.
Traditionally, surgical prophylaxis of VTE in patients undergoing high-risk orthopaedic surgery was extended for one or two weeks after the operation. However, the most recent studies carried out on this field have demonstrated that prolongation of prophylaxis with LMWH for 4-6 weeks significantly reduces the incidence of VTE (by more than half) in patients undergoing orthopaedic surgery with a high-risk of VTE.
On the contrary, thromboprophylaxis in oncological surgery is generally limited to the period of hospitalisation, despite the fact that activation of coagulation is greater and more prolonged in patients undergoing surgery for neoplastic processes than in those patients not affected by cancer. The only two studies carried out to evaluate the efficacy of the prolongation of thromboprophylaxis for 4 weeks in this type of surgery seem to indicate that the VTE incidence could be reduced even further that with one-week prophylaxis, though these do not allow to establish a definitive conclusion.
The present study aims to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, giving the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.
Additionally, some exploratory analyses will be carried out to evaluate:
- The biological effect of the sc. administration of Bemiparin (3,500 IU/day) on different biological markers involved in the tumoral development and its metastasis in patients undergoing an oncological abdominal or pelvic surgical operation.
- The effect of the sc. administration of Bemiparin (3,500 IU/day) on the evolution of the tumour in patients undergoing an oncological abdominal or pelvic surgical operation.
- The effect of the sc. administration of Bemiparin (3,500 IU/day) on the survival of the patients at 6 months from the operation.
Four Study Committees have been created for this clinical trial in order to guarantee the safety of the patients as well as the highest quality data:
- Trial Steering Committee
- Data \& Safety Monitoring Board
- Committee for the Evaluation of Phlebographies
- Committee for Adjudicating Clinical Events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 40 years of age or older, of either sex, who have given their informed consent to participate in the study.
- Patients with a malignant neoplastic process (primary or metastasic) of the gastrointestinal tract (except the oesophagus), genitourinary tract or female reproductive organs, previously diagnosed and documented, and who are programmed to undergo elective, open, curative or palliative surgery directly related to that disease.
- Patients undergoing surgery with general or spinal anaesthesia, with an estimated duration of surgery of over 30 minutes.
- Patients with a life expectancy of at least 3 months.
Key exclusion criteria (19 listed)
- Curative or palliative surgery of a malignant neoplastic process in liver, biliary tract or pancreas.
- Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods.
- Patients with macrohaematuria, active haemorrhage within the past two months, organ lesions at risk of bleeding (e.g. active peptic ulcer, haemorrhagic cerebrovascular accident, aneurysms), a history of episodes of clinically evident haemorrhage, major surgery in the previous month or an increase in the risk of bleeding due to any disturbance of haemostasis which would contraindicate the anticoagulant therapy, with the exception of bleedings episodes directly caused by tumour subjected to the surgical intervention.
- Patients with known hypersensitivity to the LMWHs, to heparin or to substances of porcine origin.
- Patients with known hypersensitivity to radiological contrast media.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BemiparinBemiparin 3.500 IU/day for 28 days compared to 8 days | Drug | – |
Primary outcome
EFFICACY: Combined incidence (from day 1 to day 20±2 after the randomisation): total DVT + non-fatal PE + all-cause mortality.
SAFETY: incidence of major bleeding (from day 1 to day 20±2 after the randomisation).
3 secondary outcomes
EFFICACY: combined and isolated incidence of DVT (Total, proximal and distal), non-fatal PE, deaths related and not related with VTE.
SAFETY: incidence of major bleeding (from day 1 to day 82±8 after the randomisation) and incidence of minor bleeding (from day 1 to day 20±2 and to day 82±8 after the randomisation).
EXPLORATORY ANALYSES: Biological markers, tumour evolution and survival at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay V Kakkar, Prof. study director
Thrombosis Research Institute (London, UK)
Paolo Prandoni, Prof. study director
Faculty of Medicine, University of Padova (Padova, Italy)
Jose Luis Balibrea-Cantero, Prof. study director
Faculty of Medicine, Complutense University (Madrid, Spain)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemiparin in people with Cancer and Venous Thromboembolism, run by Rovi Pharmaceuticals Laboratories at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Portugal, Romania, Russia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY: Combined incidence (from day 1 to day 20±2 after the randomisation): total DVT + non-fatal PE + all-cause mortality.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2010.