NCT03139487

A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism

A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism in Patients With Advanced Upper Gastrointestinal, Hepatobiliary and Pancreatic Cancer: PRIORITY

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, and randomized phase II trial designed to compare the safety and efficacy of direct oral anticoagulants 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, type of cancer, chemotherapy and medical centers.

Detailed description

This randomized II clinical trial will enrol patients with advanced upper gastrointestinal, hepatobiliary and pancreatic cancer who have venous thromboembolism (VTE), including pulmonary embolism and deep vein thrombosis. Patients will be randomized in a 1:1 ratio and stratified by performance status, type of cancer and medical centers. The enrolled patients will receive either subcutaneous dalteparin or DOAC(rivaroxaban, apixavan) according to randomization until the end of planned treatment schedules (six months), recurrence of VTE, clinical relevant bleeding, major bleeding, death or discontinuation of study treatment for any other reason (e.g. withdrawal of consent or discretion of the investigator). The primary end-point is the rate of clinical relevant bleeding event as defined as overt bleeding which was associated with medical intervention. In addition to time to clinical relevant bleeding event, time to event of major bleeding, total bleeding including minor event, time to recurrent VTE, overall bleeding rate and overall VTE recurrent rate will be analyzed to compare safety and efficacy of both anticoagulants. The final analysis will be conducted when the last enrolled patient has an event or has completed as least six months follow up in the study. Patients without bleeding and recurrent VTE events at data cut-off are censored at the last date the patient is known to be free of events. Planned interim analysis will be conducted in the intentions to treatment analysis set. The interim analysis for the randomized portion of the study will be performed when at least 40% of estimated bleeding events have been observed. The purpose of interim analysis is for early stopping of the study for safety. This study will use a Data Monitoring Committee.

Conditions

• Cancer-associated Thrombosis
• Esophageal Cancer
• Stomach Cancer
• Hepatocellular Carcinoma
• Pancreatic Cancer
• Duodenal Cancer
• Esophagogastric Junction Cancer
• Malignant Gastrointestinal Stromal Tumor
• Ampulla of Vater Cancer
• Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)

Interventions

Type	Name	Description
DRUG	Rivaroxaban	15 mg q12 hours for 3 weeks followed by 20mg q24 hours for 21 weeks
DRUG	Dalteparin	200 IU/kg q24 hours for 4 weeks followed by 150 IU/kg q24 hours for 20 weeks
DRUG	apixaban	10 mg q12 hours for 7days followed by 5mg q12 hours for 21 weeks

Timeline

• Start date: 2017-08-07
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2017-05-04
• Last updated: 2020-01-06

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study