Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy)

The aim of this prospective multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients. Primary endpoint is the incidence of clinically relevant VTE (symptomatic deep venous thrombosis (DVT) of the leg and/or pelvic and/or pulmonary embolism (PE)) within the first 3 months. Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6, 9 and 12 months as well as remission at 3, 6, 9 and 12 months, overall survival and bleeding. Trial registration: isrctn.org identifier CCT-NAPN-16752, controlled-trials.com identifier: ISRCTN02140505.An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding (5 pts vs. 6 pts, Chi2: 0.763).PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer. Its results will lead to a new understanding of the role of heparins in the prevention of venous thromboembolism and of their effect on survival, remission rates and toxicity of chemotherapeutic regimens.Pancreatic cancer is among the most common malignancies in the world with about 232,000 new cases every year [1]. Due to its aggressive nature this illness accounts for around 32,000 deaths per year in the United States [2], and around 47,000 in Western Europe [3]. The median survival time is 6–10 months with locally advanced disease and 3 to 6 months in patients with metastases. Without any specific anticancer therapy the median overall survival is between 2 to 4 months.In addition to the poor over-all prognosis the course of the disease is often complicated by thromboembolic events. Lower-extremity deep venous thrombosis, thrombophlebitis migrans, and pulmonary embolism are among the well-known presentations in pancreatic cancer. Further manifestations also include disseminated intravascular coagulation, splenic vein thrombosis, portal or superior mesenteric vein thrombosis, and spontaneous arterial thromboemb