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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ICO Paul Papin
  Angers, France Recruiting
• CH de la Côte Basque
  Bayonne, France Recruiting
• CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• CHU de Limoges
  Limoges, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting

Study contacts

• Principal investigator: Karim FIZAZI, MD — Gustave Roussy, Cancer Campus, Grand Paris
• Study coordinator: Ophélie LION
• Email: ophelie.lion@gustaveroussy.fr
• Phone: +33 (0)1 42 11 48 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.