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orally, 10 mg once daily for day1 and day 2 after femoral venepuncture

orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture

subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)

Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture

Rivaroxaban 10 MG

Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture

Rivaroxaban 20 MG

0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)

Low-molecular-weight heparin

The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.

Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients

Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture

the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture

Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0

Capital Medical University

Dean & Director

Venous Thrombosis

Upper Extremity Deep Vein Thrombosis

Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.

No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.

Rivaroxaban 10mg po daily x 90 (+/- 3 days)

Rick T Ikesaka, MD

Purpose of Pilot Trial To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism(VTE) among cancer patients.

Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.

Design:

This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa Hospital, QEII Health Science Centre and University of Alberta Hospital.

It is an open label randomized controlled trial.

Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups.

Rivaroxaban 10mg po daily x 90 (+/- 3 ) days OR Standard of Care

Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days) month and 3 months post enrollment. Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days.

Outcomes The primary feasibility outcome for the pilot study is the number of participants recruited per centre per month. We will obtain baseline details of the patient's type, location and treatment of cancer, comorbidities and medications. Secondary feasibility outcomes of the pilot study will include, consent rates, loss to follow up, adherence to therapy defining 80% or greater medication taken as having good adherence to study drug, proportion of screened patients who meet eligibility criteria.

Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily x90 days vs standard of care(usual treatment)

Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters

Pilot Feasibility Study- no current plan to share IPD

Number of Participants recruited per centre per month

Proportion of approached patients who consent to enter study.

Good adherence defined as 80% or greater study medication taken

Queen Elizabeth II Health Sciences Centre

University of Alberta

Hamilton Health Sciences Corporation

Ottawa Hospital Research Institute

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Thromboembolism

Venous Thromboembolism

Urogenital Neoplasms

Urologic Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Participants receiving study drug (Rivaroxaban)

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).

Identical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug

Placebo control

Luke T Lavallee, MDCM MSc FRCSC

David J Yachnin, MSc

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.

Background and Importance: Patients with cancer receiving systemic therapy are at high risk of venous thromboembolism (VTE). Thromboprophylaxis with antiocoagulants reduces VTEs during chemotherapy by 60%. Despite this, thromboprophylaxis is not routinely used in Canada for patients with genitourinary (GU) malignancies (bladder, testis, kidney). Reasons prophylaxis is not used are that very few GU patients were included in landmark trials evaluating DOACs, and because GU patients may be at higher risk of bleeding compared to non-GU cancer patients. The omission of GU patients from prior trials has created an important gap in knowledge because these patients have among the highest risk of VTE of all cancer patients. Prior studies have reported VTE rates during chemotherapy for bladder and testis cancer in the range of 10-15%, well above thresholds at which guidelines usually recommend thromboprophylaxis.

Hypotheses: The investigators hypothesize that thromboprophylaxis with a direct oral anticoagulant (DOAC) during systemic therapy for GU malignancies will reduce the risk of VTE with acceptable risk of major bleeding. Secondly, the investigators hypothesize that a randomized trial of thromboprophylaxis versus placebo in GU patients is feasible and needed to change care in Canada.

Research goals: The goal of this pilot study is to determine if a randomized control trial of thromboprophylaxis with rivaroxaban versus placebo in GU patients receiving systemic therapy is feasible.

Methods: This internal pilot feasibility study will randomize patients with GU malignancies receiving systemic therapy (patients) to rivaroxaban 10mg daily (intervention) versus placebo (control). The primary outcome of this internal pilot study will be feasibility of patient accrual. Feasibility will be reported as the average number of patients enrolled per month. Secondary outcomes will be time to trial initiation, number of patients enrolled per site, and proportion of patients who complete the intervention. If feasibility is confirmed, patients enrolled in the pilot will be included in the full trial using a vanguard design.

The primary outcome(s) of the full trial will be VTE (efficacy outcome) and major bleeding (safety outcome) during the intervention. Patient reported outcomes including quality of life will also be recorded.

Expected outcomes: While thromboprophylaxis is effective in cancer patients, medical guidelines only recommend prophylaxis for some patients due to limited evidence in disease-specific subgroups. Importantly, safety concerns in GU patients are a particular concern necessitating further study of this population. The investigators expect the results of this internal pilot study to prove feasibility of a full trial. The full trial will determine the net benefits/harms of prophylaxis in GU patients and change practice worldwide, regardless of the results.

VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

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

No plan to share individual participant data with other researchers.

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.

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.

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

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.

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

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.

Number of participants recruited per month at each study site

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).

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).

Canadian Institutes of Health Research (CIHR)

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

Kidney Cancer Research Network of Canada

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Patients will receive Rivaroxaban 10mg/daily for 28 days after surgery. Only one arm.

Patients in post-operative colonic cancer will receive rivaroxaban 10mg/daily for 28 days after surgery

Rafael de Athayde Soares, PhD

Rogério Cury, M.D

The chemoprophylaxis of deep vein thrombosis (DVT) with subcutaneous low-molecular-weight heparin (enoxaparin) in the postoperative period of elective surgeries is already well established in the literature and in clinical practice. However, the use of this medication can have a financial impact on the patient and the parenteral presentation itself is associated with pain at the application site, which can make it difficult for patients to adhere.

There are already robust studies in the literature demonstrating the efficacy and safety of using Rivaroxaban 10mg once a day in the prevention of deep vein thrombosis of the lower limbs in patients undergoing orthopedic knee and hip surgeries.1,2,3 Although there are already trials demonstrating the safety and efficacy of the use of rivaroxaban in the treatment of DVT and venous thromboembolism in cancer patients, there is a lack in the literature, to date, of studies on the efficacy and safety of prophylaxis with Ribaroxaban for DVT of the lower limbs in the post-operative period. operative of colorectal cancer surgeries, both open surgeries and videolaparoscopic surgeries.4 There are robust studies in the literature, with about 3645 patients undergoing colorectal cancer surgery, reporting a VTE incidence of about 0.85%. .OBJECTIVE To determine the efficacy and safety of chemoprophylaxis for DVT with Rivaroxaban in patients undergoing surgical treatment of colorectal cancer. Primary objective: prevention of DVT and VTE in patients after colorectal surgery. Secondary objective: rates of bleeding and adverse events in patients undergoing anticoagulant use.

METHOD This is a prospective, observational cohort of patients undergoing surgical treatment for colorectal cancer at the Digestive System and Coloproctology Surgery service at Hospital do Servidor Público Estadual de São Paulo. Patients undergoing chemoprophylaxis with enoxaparin and rivaroxaban to prevent lower limb DVT after surgical treatment of colorectal cancer will be included.

In the immediate postoperative period, they will be submitted to chemoprophylaxis with Enoxaparin 40mg subcutaneously 1x/day for 24 hours up to a maximum of 7 days, depending on the release of the diet and the need for a new surgical approach, and at hospital discharge, Rivaroxaban 10mg orally 1x/day will be prescribed until complete 28 days of prophylactic anticoagulation after surgery. Before surgery and after the last dose of chemoprophylaxis, patients will be evaluated with venous USG-Doppler of the lower limbs, in order to detect any possibility of asymptomatic deep vein thrombosis. In addition, 1 week after hospital discharge, patients will be evaluated for symptoms related to the lower limbs in a return visit, as well as any bleeding resulting from the use of drugs for DVT chemoprophylaxis (Table 1).

For the diagnosis of DVT we will use clinical and laboratory data and especially venous Doppler ultrasound. The main ultrasound data used for the diagnosis of DVT are vessel incompressibility and lack of flow in the analyzed vessels.5,6 Venous Doppler US will be performed by an examiner blinded to the treatment received by the patient, with compression measurements in the common femoral veins, superficial in the middle third and popliteal vein. The evaluation of venous recanalization will be through verification of total, partial or absent venous flow. In addition, the presence of venous reflux and its degree will be quantified.

Diagnostic criteria for acute DVT on Doppler: absence or decrease in venous compression; visible thrombus; increase in venous diameter; no increase in venous diameter with Valsalva; valve immobility; loss of respiratory phasicity; absence or decrease in spontaneous venous flow.

68 patients will be selected for the study. All patients must complete an informed consent form regarding the objectives and risks involved in this research

Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer

Evaluation of Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in the Surgical Treatment of Colorectal Cancer

Patients will evaluated with Duplex ultrasound. Duplex ultrasound using b mode and compressibility. All patients will be evaluated.

Patients will evaluated with Duplex ultrasound. Duplex ultrasound using b mode and compressibility. All patients will be evaluated. Safety will be evaluated regarding bleeding and no thrombosis afterall.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients	NCT03282643	Neoplasms	Rivaroxaban 10 ... Rivaroxaban 20 ... Low-molecular-w...	18 Years - 85 Years	Capital Medical University
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients	NCT03282643	Neoplasms	Rivaroxaban 10 ... Rivaroxaban 20 ... Low-molecular-w...	18 Years - 85 Years	Capital Medical University
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines	NCT03506815	Upper Extremity... Central Venous ... Cancer	Rivaroxaban 10 ...	18 Years -	Ottawa Hospital Research Institute
VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy	NCT05920343	Venous Thromboe... Urologic Cancer	Rivaroxaban 10 ... Placebo control	18 Years -	Ottawa Hospital Research Institute
Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer	NCT05303818	Deep Venous Thr... Colonic Cancer	Rivaroxaban 10 ...	18 Years - 90 Years	Hospital do Servidor Publico Estadual
VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy	NCT05920343	Venous Thromboe... Urologic Cancer	Rivaroxaban 10 ... Placebo control	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for rivaroxaban 10 mg