Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Launched by GUSTAVE ROUSSY, CANCER CAMPUS, GRAND PARIS · May 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a way to prevent blood clots in men who have advanced germ cell tumors and are starting treatment with chemotherapy. Specifically, the trial looks at whether giving a medication called thromboprophylaxis can help lower the risk of blood clots, which can be a serious complication during cancer treatment. Participants in the trial will either receive this medication or not, helping researchers determine if it truly makes a difference in preventing these clots. The study will include men aged 18 and older who have a diagnosis of good or intermediate prognosis germ cell tumors and are starting their first round of chemotherapy.

If you or a loved one qualifies for this trial, you can expect to be part of the study for about 14 to 17 weeks, depending on the number of chemotherapy sessions planned. Participants will be carefully monitored throughout the study. To be eligible, patients should not have any prior treatment for cancer and must meet specific health criteria, such as having certain risk factors for blood clots. It’s essential for interested individuals to understand the trial fully and provide informed consent before joining. This study is currently recruiting participants, and those interested should talk to their healthcare team for more information.

Gender

MALE

Eligibility 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