Clinical Trial: A Randomized Phase II Study to Compare the Safety and Efficacy of Dalteparin vs. Rivaroxaban for Cancer-associated Venous Thromboembolism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Oral Rivaroxaban for Cancer-associated Venous Thromboembolism in Patients With Advanced Uppe

Brief Summary: This is an open label, multi-center, and randomized phase II trial designed to compare the safety and efficacy of oral rivaroxaban and subcutaneous dalteparin in patients with acute venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based on a group sequential design. Enrolled patients will be randomized in a 1:1 ratio. Patients will be stratified by performance status (ECOG performance status 0-1 versus ≥2) and type of cancer.