NCT05874063

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P50-P75 for phase_3

Timeline
21mo left

Started Oct 2023

Typical duration for phase_3

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2023Feb 2028

First Submitted

Initial submission to the registry

May 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

4.3 years

First QC Date

May 16, 2023

Last Update Submit

June 13, 2025

Conditions

Germ Cell Tumor

Outcome Measures

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)

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

Study Arms (3)

Experimental for high-risk patients

EXPERIMENTAL

Thromboprophylaxis in addition of the standard chemotherapy

Drug: Thromboprophylaxis

Control for high-risk patients

NO INTERVENTION

No thromboprophylaxis in addition of the standard chemotherapy

Low-risk patients

NO INTERVENTION

No thromboprophylaxis in addition of the standard chemotherapy

Interventions

ThromboprophylaxisDRUG

Thromboprophylaxis in addition of the standard chemotherapy

Experimental for high-risk patients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

ICO Paul Papin

Angers, 49100, France

RECRUITING

CH de la Côte Basque

Bayonne, 64100, France

RECRUITING

Institut Bergonié

Bordeaux, 33000, France

NOT YET RECRUITING

CHU de Brest

Brest, 29200, France

NOT YET RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38000, France

NOT YET RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

CHU de Limoges

Limoges, 87000, France

RECRUITING

Centre Léon Bérard

Lyon, 69000, France

RECRUITING

Institut Paoli-Calmettes

Marseille, 13273, France

NOT YET RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Hôpital Saint Louis

Paris, 75010, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

RECRUITING

Institut Godinot

Reims, 51726, France

NOT YET RECRUITING

Centre Eugène Marquis

Rennes, 35000, France

RECRUITING

CHU de St Etienne

Saint-Etienne, 42270, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

HIA Bégin

Saint-Mandé, 94160, France

RECRUITING

ICANS

Strasbourg, 67200, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

NOT YET RECRUITING

Oncopole Claudius Regaud

Toulouse, 31059, France

NOT YET RECRUITING

CHU Bretonneau

Tours, 37044, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasms

Study Officials

  • Karim FIZAZI, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ophélie LION

CONTACT

+33 (0)1 42 11 48 41ophelie.lion@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 24, 2023

Study Start

October 17, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(26)