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Study evaluating thromboprophylaxis in patients with advanced germ cell tumours of good or intermediate prognosis
EU CTIS ID: 2022-502426-41-00
What this study is testing
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 (i.e. patients with elevated baseline LDH or BSA > 1.9 m² or RPLN> 5 cm).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the IGCCCG Group)
- 2. ≥ 18 years
- 3. Suitable for first-line cisplatin-based chemotherapy
- 4. No prior systemic cytotoxic therapy
- 5. Additional criteria for patients who will be randomized, (VTE high-risk patients):o LDH>1UNL and/or , o BSA > 1.9 m² and/or, o > 5 cm long axis retroperitoneal lymph nodes
- 6. 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.
You likely can't join if
- 1. Brain metastasis
- 10. Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor
- 11. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- 2. History of VTE
- 3. Concomitant use of anticoagulants or antiaggregants
- 4. Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula
See the full eligibility criteria
- 1. Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the IGCCCG Group)
- 2. ≥ 18 years
- 3. Suitable for first-line cisplatin-based chemotherapy
- 4. No prior systemic cytotoxic therapy
- 5. Additional criteria for patients who will be randomized, (VTE high-risk patients):o LDH>1UNL and/or , o BSA > 1.9 m² and/or, o > 5 cm long axis retroperitoneal lymph nodes
- 6. 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.
- 7. Patients must be affiliated to a social security system or beneficiary of the same
- 1. Brain metastasis
- 10. Participation in another clinical study with an investigational product during the last 4 weeks, and while on study treatment without the approval from sponsor
- 11. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- 2. History of VTE
- 3. Concomitant use of anticoagulants or antiaggregants
- 4. Renal impairment defined as creatinine clearance less than 50 ml/min using Cockcroft-Gault formula
- 5. Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients
- 6. 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 mm Hg or diastolic blood pressure > 110 mm Hg)
- 7. Low baseline platelet count (< 100 X 10 9 /L) or history of heparin-induced thrombocytopenia
- 8. 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
- 9. Extensive metastatic disease at high risk of bleeding, e.g. prevalent choriocarcinoma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.