Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

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).

NCT Number	NCT05874063
Lead Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Conditions	Germ Cell Tumor
Enrollment	387 participants
Start Date	2023-10-17
Primary Completion	2028-02 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2025-06-15