NCT05874063

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	Thromboprophylaxis	Thromboprophylaxis in addition of the standard chemotherapy

Timeline

• Start date: 2023-10-17
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2023-05-24
• Last updated: 2025-06-15

Locations

26 sites across 1 country: France