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Preventing blood clots in patients with advanced germ cell tumors undergoing chemotherapy

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Phase 3 Interventional Gustave Roussy, Cancer Campus, Grand Paris · NCT05874063

This study is testing whether a blood clot prevention treatment can help people with advanced germ cell tumors who are getting chemotherapy avoid serious blood clots.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment387 (estimated)
Ages18 Years and up
SexMale
SponsorGustave Roussy, Cancer Campus, Grand Paris Academic / other
Drugs / interventionschemotherapy
Locations26 sites (Angers and 25 other locations)
Trial IDNCT05874063 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of thromboprophylaxis in reducing the risk of venous thromboembolic events (VTE) in patients with good and intermediate prognosis metastatic germ cell tumors receiving first-line cisplatin-based chemotherapy. Participants will be randomized into two groups: one receiving thromboprophylaxis and the other receiving standard care without it. The study will last between 14 to 17 weeks, depending on the number of chemotherapy cycles planned. The goal is to achieve a significant reduction in the incidence of VTE among high-risk patients.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with good or intermediate prognosis germ cell tumors who are eligible for first-line cisplatin-based chemotherapy.

Not a fit: Patients with brain metastasis, a history of venous thromboembolic events, or those currently using anticoagulants or antiaggregants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly lower the risk of blood clots in patients undergoing chemotherapy for germ cell tumors, improving their overall treatment outcomes.

How similar studies have performed: Other studies have shown promising results with thromboprophylaxis in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Angers and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Germ Cell Tumor
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.