Preventing blood clots in cancer patients receiving treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.