A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)

NCT00785421 Phase 2/Phase 3 COMPLETED

To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm. N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%

Details

Lead sponsor	CONKO-Studiengruppe
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	312
Start date	2004-04
Completion	2009-06

Conditions

• Pancreatic Cancer

Interventions

• enoxaparin
• chemotherapy with LMWH - enoxaparin
• only chemotherapy

Primary outcomes

• DVT/TVE event rate — After 12 events and after 24 events or after 540 pts recruited

Countries

Germany