Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH). Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.

Official Title
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CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study

Conditions
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Venous Thromboembolism, Cancer

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: low-molecular heparine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed and objectively confirmed acute venous thromboembolism Active malignancy Life expectancy of at least 6 months Performance-Status according to Karnofsky Performance Scale ≥ 70 % Patient's compliance and geographical situation allowing an adequate follow up platelets ≥ 100.000 /μl, INR < 1.5, PTT < 40 sec. written informed consent of the patient prior to any procedure in connection with the study male and female patients with an age of at least 18 years Exclusion Criteria: therapeutic anticoagulation > 96 hours prior to study treatment known allergic reactions against the study drugs or the substances included therein known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis acute clinically relevant bleeding in the last 2 weeks any history of spontaneous major/cerebral bleeding history of heparin induced thrombocytopenia II pregnant or breast-feeding women. Women of child-bearing potential must have a negative pregnancy test performed < 7 days prior to start of the treatment severe renal insufficiency (GFR < 30 ml/min) liver disease with coagulation impairment, including Child B and C cirrhosis acute medical illness treatment of the underlying cancer with experimental therapies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban<br>Arm A: Rivaroxaban | Drug: Rivaroxaban<br>* Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months<br>* Other names: Xarelto;|
| Active Comparator: low-molecular heparine<br>Arm B: standard treatment with low-molecular heparine | Drug: low-molecular heparine<br>* LMWH in therapeutic dosage (1-2× daily s.c.) according to standards of the individual study center, using licensed dosages, e.g. Enoxaparin 1 mg/kg BW twice daily Tinzaparin 175 I.E./kg BW once daily Dalteparin 200 I.E./kg BW once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin |  | From randomization to 4 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment |  | From randomization to 3 months after treatment start | 
| Exploratory analysis for time on treatment |  | From randomization to 12 weeks after treatment start | 
| Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics |  | From randomization to end of follow up (up to 24 weeks) | 
| Rate of myocardial infarction and ischemic stroke |  | From randomization to end of follow up (up to 24 weeks) | 
| Compliance of patients (adherence) |  | From randomization to end of follow up (up to 24 weeks) | 
| Overall mortality 3 and 6 months after randomization |  | From randomization to 3 and 6 months after randomization | 
| Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM |  | 4 weekly, up to 12 weeks | 
| Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months |  | From randomization to 3 months after randomization | 
| Rate of minor bleedings within 3 months |  | From randomization to 3 months after randomization |