Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors - Trial NCT05874063
Access comprehensive clinical trial information for NCT05874063 through Pure Global AI's free database. This Phase 3 trial is sponsored by Gustave Roussy, Cancer Campus, Grand Paris and is currently Not yet recruiting. The study focuses on Germ Cell Tumor. Target enrollment is 387 participants.
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Study Focus
Sponsor & Location
Gustave Roussy, Cancer Campus, Grand Paris
Timeline & Enrollment
Phase 3
Jul 01, 2023
Nov 01, 2027
Primary Outcome
Proportion of patients undergoing a thromboembolic event
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05874063
Non-Device Trial