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NCT05874063

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Gustave Roussy, Cancer Campus, Grand Paris·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Germ Cell Tumor
Drug/Device/Intervention
Thromboprophylaxis
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Timeline & enrollment
Phase
Phase 3
Start date
Jul 01, 2023
End date
Nov 01, 2027
Enrollment
387 participants
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
Malignant neoplasmsMalignant neoplasm: JejunumMalignant neoplasm: PrepuceMalignant neoplasm: Female genital organ, unspecifiedMalignant neoplasm: Vulva, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05874063
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.