Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Recruiting
Phase 3
Interventional Study
Germ Cell Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 387 (estimated)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Other
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About This Trial
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 (receivin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the International Germ Cell Cancer Collaborative Group)
* Older than 18 years
* Suitable for first-line cisplatin-based chemotherapy
* No prior systemic cytotoxic therapy
* Additional criteria for pat…
Contacts