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Recruiting Phase 3

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

NCT05874063 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2023-10-17
Last updated
2025-06-15

Condition(s) studied

Germ Cell Tumor

Investigational drug(s) / intervention(s)

Thromboprophylaxis

Thromboprophylaxis: Thromboprophylaxis in addition of the standard chemotherapy

Study 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).

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 patients who will be randomized (Venous Thromboembolic Event (VTE) high-risk patients): Lactate dehydrogenase higher than 1 Upper Normal Level and/or Body Surface Area higher than 1.9 and/or longer than 5 cm long axis retroperitoneal lymph nodes * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: * Brain metastasis * History of VTE * Concomitant use of anticoagulants or antiaggregants * Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula * Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients * Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to closure) within 4 weeks or planned during the study treatment period * Severe uncontrolled high blood pressure (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg) * Low baseline platelet count (\< 100 X 10\^9 /L) or history of heparin-induced thrombocytopenia * Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities * Extensive metastatic disease at high risk of bleeding, e.g. prevalent choriocarcinoma * Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Primary outcome measure(s)

  • Proportion of patients undergoing a thromboembolic event — from randomization up to 6 weeks after D1 of the last cycle of chemotherapy or up to the residual masses surgery, whichever occurs first.
    (composite end point: symptomatic or asymptomatic (incidental finding) venous thrombosis or pulmonary embolism or unexplained death)

Trial sites (26)

FacilityCityRegionStatus
ICO Paul Papin Angers France Recruiting
CH de la Côte Basque Bayonne France Recruiting
Institut Bergonié Bordeaux France Not Yet Recruiting
CHU de Brest Brest France Not Yet Recruiting
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
Groupe Hospitalier Mutualiste de Grenoble Grenoble France Not Yet Recruiting
Centre Oscar Lambret Lille France Recruiting
CHU de Limoges Limoges France Recruiting
Centre Léon Bérard Lyon France Recruiting
Institut Paoli-Calmettes Marseille France Not Yet Recruiting
Centre Antoine Lacassagne Nice France Recruiting
Hôpital Saint Louis Paris France Recruiting
Hôpital Tenon Paris France Not Yet Recruiting
CHU de Poitiers Poitiers France Recruiting
Clinique La Croix du Sud Quint-Fonsegrives France Recruiting
Institut Godinot Reims France Not Yet Recruiting
Centre Eugène Marquis Rennes France Recruiting
CHU de St Etienne Saint-Etienne France Recruiting
Institut de Cancérologie de l'Ouest Saint-Herblain France Recruiting
HIA Bégin Saint-Mandé France Recruiting
ICANS Strasbourg France Recruiting
Hôpital Foch Suresnes France Not Yet Recruiting
Oncopole Claudius Regaud Toulouse France Not Yet Recruiting
CHU Bretonneau Tours France Recruiting
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France Recruiting
Gustave Roussy Villejuif France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05874063 on ClinicalTrials.gov ↗ ← All trials in France