CClinicalTrials.gg
RecruitingNCT05874063GIG-TUpdated Jun 15, 2025

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

A Phase 3 interventional study of Thromboprophylaxis in Germ Cell Tumor, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 26 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
387
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

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).

02

Conditions studied

  • Germ Cell Tumor
03

In context

Neoplasms, Germ Cell and Embryonal

291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.

This study's planned enrollment of 387 is above the median of 37 across 211 interventional studies indexed under Neoplasms, Germ Cell and Embryonal.

Browse Neoplasms, Germ Cell and Embryonal studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
387 participants (estimated)

Study arms

  • Experimental
    Experimental for high-risk patients

    Thromboprophylaxis in addition of the standard chemotherapy

    Drug: Thromboprophylaxis

  • No intervention
    Control for high-risk patients

    No thromboprophylaxis in addition of the standard chemotherapy

  • No intervention
    Low-risk patients

    No thromboprophylaxis in addition of the standard chemotherapy

Interventions

  • DrugThromboprophylaxis

    Thromboprophylaxis in addition of the standard chemotherapy

06

What researchers measure

Primary outcomes

  1. Proportion of patients undergoing a thromboembolic event

    (composite end point: symptomatic or asymptomatic (incidental finding) venous thrombosis or pulmonary embolism or unexplained death)

    Time frame: from randomization up to 6 weeks after D1 of the last cycle of chemotherapy or up to the residual masses surgery, whichever occurs first.

07

Study locations

18 of 26 sites recruiting
  • ICO Paul Papin
    Angers, 49100, France
    • Elouen BOUGHALEM, MD · Contact
    Recruiting
  • CH de la Côte Basque
    Bayonne, 64100, France
    • Louis FRANCOIS, MD · Contact
    Recruiting
  • Institut Bergonié
    Bordeaux, 33000, France
    • Guilhem ROUBAUD, MD · Contact
    Not yet recruiting
  • CHU de Brest
    Brest, 29200, France
    • Benjamin AUBERGER, MD · Contact
    Not yet recruiting
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63000, France
    • Sébastien BAILLY, MD · Contact
    Recruiting
  • Groupe Hospitalier Mutualiste de Grenoble
    Grenoble, 38000, France
    • Eve FAUGERAS, MD · Contact
    Not yet recruiting
  • Centre Oscar Lambret
    Lille, 59000, France
    • Guillaume CARBONNELLE, MD · Contact
    Recruiting
  • CHU de Limoges
    Limoges, 87000, France
    • Tiffany DARBAS, MD · Contact
    Recruiting
  • Centre Léon Bérard
    Lyon, 69000, France
    • Aude FLECHON, MD · Contact
    Recruiting
  • Institut Paoli-Calmettes
    Marseille, 13273, France
    • Mathilde GUERIN, MD · Contact
    Not yet recruiting
  • Centre Antoine Lacassagne
    Nice, 06189, France
    • Agnès DUCOULOMBIER, MD · Contact
    Recruiting
  • Hôpital Saint Louis
    Paris, 75010, France
    • Clément DUMONT, MD · Contact
    Recruiting
  • Hôpital Tenon
    Paris, 75020, France
    • Mathieu JAMELOT, MD · Contact
    Not yet recruiting
  • CHU de Poitiers
    Poitiers, 86000, France
    • Sheik EMAMBUX, MD · Contact
    Recruiting
  • Clinique La Croix du Sud
    Quint-Fonsegrives, 31130, France
    • Francesco RICCI, MD · Contact
    Recruiting
  • Institut Godinot
    Reims, 51726, France
    • Camille MAZZA, MD · Contact
    Not yet recruiting
  • Centre Eugène Marquis
    Rennes, 35000, France
    • Bettina BOUTRUCHE, MD · Contact
    Recruiting
  • Institut de Cancérologie de l'Ouest
    Saint-Herblain, 44805, France
    • Emmanuelle BOMPAS, MD · Contact
    Recruiting
  • HIA Bégin
    Saint-Mandé, 94160, France
    • Carole HELISSEY, MD · Contact
    Recruiting
  • CHU de St Etienne
    Saint-Étienne, 42270, France
    • Pierre CORNILLON, MD · Contact
    Recruiting
  • ICANS
    Strasbourg, 67200, France
    • Laure PIERARD, MD · Contact
    Recruiting
  • Hôpital Foch
    Suresnes, 92150, France
    • Christine ABRAHAM, MD · Contact
    Not yet recruiting
  • Oncopole Claudius Regaud
    Toulouse, 31059, France
    • Loïc MOUREY, MD · Contact
    Not yet recruiting
  • CHU Bretonneau
    Tours, 37044, France
    • Mathilde CANCEL, MD · Contact
    Recruiting
  • Institut de Cancérologie de Lorraine
    Vandoeuvre les nancy, 54500, France
    • Camille SIMON, MD · Contact
    Recruiting
  • Gustave Roussy
    Villejuif, 94800, France
    • Karim FIZAZI, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05874063
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
May 24, 2023
Start date
Oct 17, 2023
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jun 15, 2025

Study contacts

Ophélie LION
Contact
ophelie.lion@gustaveroussy.fr
+33 (0)1 42 11 48 41
Karim FIZAZI, MD
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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