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Germ Cell TumorPhase 3GIG-TNCT05874063

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

A Phase 3 study testing Thromboprophylaxis in people with Germ Cell Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 26 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Germ Cell Tumor
What is being tested?
Thromboprophylaxis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
387 participants
Where
26 sitesFrance
Study dates
17 Oct 2023to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ophélie LION contact

+33 (0)1 42 11 48 41

ophelie.lion@gustaveroussy.fr

26 sites in 1 country

France26 sites, 26 recruiting

  • ICO Paul Papin

    Angers, 49100

    Elouen BOUGHALEM, MD

    Recruiting

  • CH de la Côte Basque

    Bayonne, 64100

    Louis FRANCOIS, MD

    Recruiting

  • Institut Bergonié

    Bordeaux, 33000

    Guilhem ROUBAUD, MD

    Not yet recruiting

  • CHU de Brest

    Brest, 29200

    Benjamin AUBERGER, MD

    Not yet recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Sébastien BAILLY, MD

    Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38000

    Eve FAUGERAS, MD

    Not yet recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Guillaume CARBONNELLE, MD

    Recruiting

  • CHU de Limoges

    Limoges, 87000

    Tiffany DARBAS, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69000

    Aude FLECHON, MD

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13273

    Mathilde GUERIN, MD

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Agnès DUCOULOMBIER, MD

    Recruiting

  • Hôpital Saint Louis

    Paris, 75010

    Clément DUMONT, MD

    Recruiting

  • Hôpital Tenon

    Paris, 75020

    Mathieu JAMELOT, MD

    Not yet recruiting

  • CHU de Poitiers

    Poitiers, 86000

    Sheik EMAMBUX, MD

    Recruiting

  • Clinique La Croix du Sud

    Quint-Fonsegrives, 31130

    Francesco RICCI, MD

    Recruiting

  • Institut Godinot

    Reims, 51726

    Camille MAZZA, MD

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes, 35000

    Bettina BOUTRUCHE, MD

    Recruiting

  • CHU de St Etienne

    Saint-Etienne, 42270

    Pierre CORNILLON, MD

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

    Emmanuelle BOMPAS, MD

    Recruiting

  • HIA Bégin

    Saint-Mandé, 94160

    Carole HELISSEY, MD

    Recruiting

  • ICANS

    Strasbourg, 67200

    Laure PIERARD, MD

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    Christine ABRAHAM, MD

    Not yet recruiting

  • Oncopole Claudius Regaud

    Toulouse, 31059

    Loïc MOUREY, MD

    Not yet recruiting

  • CHU Bretonneau

    Tours, 37044

    Mathilde CANCEL, MD

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54500

    Camille SIMON, MD

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Karim FIZAZI, MD

    Recruiting

Other trials in France

About this study

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).

Conditions
Germ Cell Tumor
Being tested
Thromboprophylaxis
Medical subject headings
Neoplasms, Germ Cell and Embryonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThromboprophylaxisDrug

    Thromboprophylaxis in addition of the standard chemotherapy

Study groups in NCT05874063
Study groupRoleWhat they receive
Experimental for high-risk patientsExperimentalThromboprophylaxis in addition of the standard chemotherapy
Receives: Drug: Thromboprophylaxis
Control for high-risk patientsNo interventionNo thromboprophylaxis in addition of the standard chemotherapy
Low-risk patientsNo interventionNo thromboprophylaxis in addition of the standard chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients undergoing a thromboembolic event

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start17 Oct 2023
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
387 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05874063
Sponsor's protocol ID
2022-502426-41-00
Other IDs
CSET 2022/3510
Acronym
GIG-T
Status last verified
Jun 2025
First submitted
16 May 2023
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thromboprophylaxis in people with Germ Cell Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 26 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ophélie LION (+33 (0)1 42 11 48 41, ophelie.lion@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients undergoing a thromboembolic event (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05874063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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