Study evaluating thromboprophylaxis in patients with advanced germ cell tumours of good or intermediate prognosis

Phase 1

Recruiting

• Conditions: Thromboprophylaxis in good and intermediate prognosis advanced germ cell tumors; MedDRA version: 20.0Level: LLTClassification code: 10075819Term: Testicular germ cell tumor Class: 10029104; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502426-41-00
• Lead Sponsor: Institut Gustave Roussy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-26
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 387

Inclusion 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.Signed informed consent, 6.Additional criteria for patients who will be randomized, (VTE high-risk patients):o LDH>1UNL and/or , oBSA > 1.9 and/or, o > 5 cm long axis retroperitoneal lymph nodes, 7.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., 8.Patients must be affiliated to a social security system or beneficiary of the same

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified