Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05874063
PHASE3

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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

DRUG

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