VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

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

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

Treatments tested in this trial

  • Rivaroxaban 10 MG
  • Placebo control

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ottawa Hospital Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Collaborator

Kidney Cancer Research Network of Canada

Collaborator