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Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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).
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
387
Start Date
2023-10-17
Completion Date
2028-02
Last Updated
2025-06-15
Healthy Volunteers
No
Conditions
Interventions
Thromboprophylaxis
Thromboprophylaxis in addition of the standard chemotherapy
Locations (26)
ICO Paul Papin
Angers, France
CH de la Côte Basque
Bayonne, France
Institut Bergonié
Bordeaux, France
CHU de Brest
Brest, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Centre Oscar Lambret
Lille, France
CHU de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Centre Antoine Lacassagne
Nice, France
Hôpital Saint Louis
Paris, France
Hôpital Tenon
Paris, France
CHU de Poitiers
Poitiers, France
Clinique La Croix du Sud
Quint-Fonsegrives, France
Institut Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
CHU de St Etienne
Saint-Etienne, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
HIA Bégin
Saint-Mandé, France
ICANS
Strasbourg, France
Hôpital Foch
Suresnes, France
Oncopole Claudius Regaud
Toulouse, France
CHU Bretonneau
Tours, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Gustave Roussy
Villejuif, France