Preventing blood clots in cancer patients receiving treatment
Prevention of Thromboembolism With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
This study is testing if the blood thinner rivaroxaban can help prevent blood clots in cancer patients with genitourinary cancers who are starting treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05920343 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using rivaroxaban, a direct oral anticoagulant, to prevent venous thromboembolism (VTE) in patients with genitourinary cancers who are starting systemic therapy. It aims to determine if thromboprophylaxis can reduce the risk of blood clots while maintaining an acceptable safety profile regarding bleeding risks. The study will compare rivaroxaban to a placebo in a randomized controlled format to assess feasibility and potential benefits for this specific patient population. The research addresses a significant gap in knowledge, as previous studies have largely excluded genitourinary cancer patients from thromboprophylaxis trials.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are starting systemic therapy for active genitourinary cancers, excluding prostate cancer.
Not a fit: Patients who require anticoagulation for other medical reasons or have severe renal or liver insufficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of blood clots in genitourinary cancer patients undergoing systemic therapy, improving their overall treatment outcomes.
How similar studies have performed: While studies have shown the effectiveness of thromboprophylaxis in other cancer types, this specific approach for genitourinary cancers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Concomitant use of strong inducers or inhibitors of CYP3A4 or glycoprotein-P (known interaction with rivaroxaban). * Severe renal insufficiency (Creatinine clearance \<30 mL/min (defined by Cockcroft-Gault)) * Severe liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis) * Thrombocytopenia \< 50 x 109/L * Life expectancy under 6 months. * Pregnancy (if child bearing age under 50 and sexually active, documentation of use of effective contraception or negative B- HCG is required) * Patient is breastfeeding or lactating * History of condition at increased bleeding risk including, but not limited to: cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the previous 4 weeks. * Chronic hemorrhagic disorder * Inability to adhere to protocol or obtain consent. * Patients may be excluded from the study for other reasons, at the investigator's discretion.
Where this trial is running
Ottawa, Ontario
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Luke T Lavallee, MDCM MSc FRCSC — Ottawa Hospital Research Institute
- Study coordinator: Luke T Lavallee, MDCM MSc FRCSC
- Email: lulavallee@toh.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.