Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors (GIG-T)

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).

Study Overview

• Status: Recruiting
• Conditions: Germ Cell Tumor
• Intervention / Treatment: Drug: Thromboprophylaxis

• Study Type: Interventional
• Enrollment (Estimated): 387
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ophélie LION; Phone Number: +33 (0)1 42 11 48 41; Email: ophelie.lion@gustaveroussy.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • ICO Paul Papin
    • Contact: Elouen BOUGHALEM, MD
  • Bayonne, France, 64100
    • Recruiting
    • CH de la Côte Basque
    • Contact: Louis Francois, MD
  • Bordeaux, France, 33000
    • Not yet recruiting
    • Institut Bergonie
    • Contact: Guilhem Roubaud, MD
  • Brest, France, 29200
    • Not yet recruiting
    • CHU de Brest
    • Contact: Benjamin AUBERGER, MD
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Sébastien BAILLY, MD
  • Grenoble, France, 38000
    • Not yet recruiting
    • Groupe hospitalier mutualiste de Grenoble
    • Contact: Eve FAUGERAS, MD
  • Lille, France, 59000
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Guillaume CARBONNELLE, MD
  • Limoges, France, 87000
    • Recruiting
    • CHU de Limoges
    • Contact: Tiffany DARBAS, MD
  • Lyon, France, 69000
    • Recruiting
    • Centre Leon Berard
    • Contact: Aude FLECHON, MD
  • Marseille, France, 13273
    • Not yet recruiting
    • Institut Paoli-Calmettes
    • Contact: Mathilde GUERIN, MD
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Agnès DUCOULOMBIER, MD
  • Paris, France, 75010
    • Recruiting
    • Hopital Saint Louis
    • Contact: Clément DUMONT, MD
  • Paris, France, 75020
    • Not yet recruiting
    • Hopital Tenon
    • Contact: Mathieu JAMELOT, MD
  • Poitiers, France, 86000
    • Recruiting
    • Chu de Poitiers
    • Contact: Sheik Emambux, MD
  • Quint-Fonsegrives, France, 31130
    • Recruiting
    • Clinique La Croix Du Sud
    • Contact: Francesco RICCI, MD
  • Reims, France, 51726
    • Not yet recruiting
    • Institut Godinot
    • Contact: Camille MAZZA, MD
  • Rennes, France, 35000
    • Recruiting
    • Centre Eugene Marquis
    • Contact: Bettina BOUTRUCHE, MD
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancerologie de L'Ouest
    • Contact: Emmanuelle BOMPAS, MD
  • Saint-Mandé, France, 94160
    • Recruiting
    • Hia Begin
    • Contact: Carole Helissey, MD
  • Saint-Étienne, France, 42270
    • Recruiting
    • CHU de St Etienne
    • Contact: Pierre CORNILLON, MD
  • Strasbourg, France, 67200
    • Recruiting
    • ICANS
    • Contact: Laure PIERARD, MD
  • Suresnes, France, 92150
    • Not yet recruiting
    • Hôpital Foch
    • Contact: Christine ABRAHAM, MD
  • Toulouse, France, 31059
    • Not yet recruiting
    • Oncopole Claudius Regaud
    • Contact: Loïc MOUREY, MD
  • Tours, France, 37044
    • Recruiting
    • CHU Bretonneau
    • Contact: Mathilde CANCEL, MD
  • Vandoeuvre les nancy, France, 54500
    • Recruiting
    • Institut de Cancerologie de Lorraine
    • Contact: Camille SIMON, MD
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
    • Contact: Karim FIZAZI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental for high-risk patients; Thromboprophylaxis in addition of the standard chemotherapy	Drug: Thromboprophylaxis; Thromboprophylaxis in addition of the standard chemotherapy
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Investigators: Principal Investigator: Karim FIZAZI, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: 2022-502426-41-00; CSET 2022/3510 (Other Identifier: Gustave Roussy ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No