Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Status:
Not yet recruiting
Trial end date:
2027-11-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to assess the efficacy of thromboprophylaxis in preventing
venous thromboembolic events (VTE) in good and intermediate prognosis patients with
metastatic germ cell cancer (GCT) undergoing first-line cisplatin-based chemotherapy with
risk factors for developing a thromboembolic event .
The high-risk patients will be randomized between two treatments arm (receiving a
thromboprophylaxis in the experimental arm, or no thromboprophylaxis in the control arm). The
low-risk patients will be observed without any thromboprophylaxis. Patients will participate
in the study for 14-17 weeks depending on the planned number of cycles of chemotherapy.
Researchers will compare an experimental arm with thromboprophylaxis and a control arm
without thromboprophylaxis to detect an absolute decrease of 12% of the proportion of
patients having experienced a VTE, from 21% (high risk patients, control arm) to 9% (high
risk patients, experimental arm).