VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

ConditionsVenous Thromboembolism Urologic Cancer

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorOttawa Hospital Research Institute

About this trial

Patients with genitourinary cancers (ex: bladder, testicular, kidney) are at high risk of developing blood clots if they receive systemic therapy (ex: chemotherapy, immunotherapy). Blood clots cause pain, may require hospitalization and invasive testing, and in some cases cause death. In fact, blood clots are one of the leading causes of death in patients with cancer. Furthermore, patients who develop a blood clot require medication to thin the blood for a prolonged (sometimes indefinite) period of time, and this can disrupt other important cancer treatments. Studies have shown that using low dose blood thinners to prevent blood clots during systemic therapy is effective in some patients with cancer. However very few patients in these studies had genitourinary cancers, therefore physicians in Canada are not sure if recommending blood thinners to patients with genitourinary cancers is useful or safe. Safety is a primary concern because blood thinners may cause bleeding, and patients with genitourinary cancers may have higher risk of bleeding than patients with other types of cancer. The investigators hypothesize that blood thinners are effective and safe for reducing blood clots in patients with genitourinary cancers. The objective of this study is to determine if a large clinical trial testing the effectiveness and safety of low dose blood thinners for preventing blood clots in patients with genitourinary cancers receiving systemic therapy is feasible.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are starting systemic therapy for active GU cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except for prostate cancer.

Age ≥ 18

Eligible systemic therapies include chemotherapy, targeted therapies (tyrosine kinase inhibitors and antiangiogenic therapy), and immunotherapies.

Patients must be initiating systemic therapy with a minimum planned treatment duration of 8 weeks.

Disqualifiers

Anticoagulation (prophylactic or therapeutic dosing) required for another indication for entire duration of study

Known allergies to rivaroxaban

Concomitant use of dual antiplatelet therapy (two antiplatelet medications oncomitantly)

Ongoing refractory bleeding that may be exacerbated by rivaroxaban.

Trial design

Design model

Parallel

Treatments tested in this trial

Rivaroxaban 10 MG
Drug
The intervention in the experimental arm will be rivaroxaban, 10 mg PO once daily (prophylactic dosing) for 180 days after the start of systemic therapy or until one of the primary study outcomes occurs (VTE or major bleeding).
Placebo control
Other intervention
Identical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: RivaroxabanExperimental treatment 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility of enrollment, assesed by the number of patients accrued per month

The primary outcome of this Pilot Trial is feasibility of enrollment. Feasibility will be measured by the average number of patients accrued per month.

Time frame

Enrollment

Secondary outcomes

Adherence to the study intervention, assessed as the proportion of patients taking the study medication >80% of days taken during the study period,

This outcome will measure patient adherence to the study intervention (defined as \>80% of medication taken during the study intervention period). This will be assessed using pill counts during study follow-ups.

Time frame

During 180 days of study intervention

Recruitment rate

Number of participants recruited per month at each study site

Time frame

Enrollment

VTE incidence

VTE will be recorded and adjudicated similarly to the full trial. Outcomes will be examined in aggregate to ascertain an estimate of baseline risk for patients in the trial. VTE outcomes will NOT be examined or reported by allocation group in the Pilot so all patients can be included in Full Trial analyses (internal pilot design).

Time frame

During 180 days of study intervention

Bleeding incidence

Bleeding outcomes (major and minor) will be recorded and adjudicated similarly to the full trial. Outcomes will be examined in aggregate to ascertain an estimate of baseline risk for patients in the trial. Bleeding outcomes will NOT be examined or reported by allocation group in the Pilot so all patients can be included in Full Trial analyses (internal pilot design).

Time frame

During 180 days of study intervention

Other outcomes

VTE-related death

VTE-related death will be collected during the pilot but will not be analyzed until the full trial. VTE-related death will assess the frequency of deaths among participants directly related to a VTE event.

Time frame

During 180 days of study intervention

Overall survival

Overall survival will be collected during the pilot but will not be analyzed until the full trial. Overall survival will assess the frequency with which participants die by any cause during the intervention.

Time frame

During 180 days of study intervention

Health-related Quality of Life assessed using the EQ-5D-5L Score

Health-related Quality of Life will be collected during the pilot but will not be analyzed until the full trial. Health-related Quality of Life will be assessed using the EQ-5D-5L questionnaire. EQ-5D-5L contains two scores: The VAS ranges from 0-100 and represents a patient's sense of their overall health. Higher VAS scores represent a better outcome. The second measure is the EQ-5D-5L index which ranges from 0-1 (scores are reported with three decimal points) and shows quality of life along 5 dimensions which are weighted based on regional values in the final index score. Higher index scores represent a better outcome

Time frame

During 180 days of study intervention

Incremental cost-effectiveness ratio

Incremental cost-effectiveness ratio will be collected during the pilot but will not be analyzed until the full trial. Incremental cost-effectiveness ratio will take the form of a cost utility analysis with outcome expressed as incremental cost per quality adjusted life year (QALY) gained.

Time frame

During 180 days of study intervention