Prevention of Thromboembolism With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy: A Randomized Placebo-Controlled, Double-Blind Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Contact Information
Primary
Luke T Lavallee, MDCM MSc FRCSC
lulavallee@toh.ca
613-737-8899
Backup
David J Yachnin, MSc
dyachnin@toh.ca
613-798-5555
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2026-10
Participants
Target number of participants: 120
Treatments
Experimental: Rivaroxaban
Participants receiving study drug (Rivaroxaban)
Placebo_comparator: Control
Participants receiving matched placebo
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Kidney Cancer Research Network of Canada, Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov