About this trial
The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls
Eligibility criteria
Qualifiers
Written informed consent and HIPAA authorization for release of personal health information
Age ≥ 18 years and ≤ 70 years at the time of consent
Histological confirmation of stage IS or IIA or higher testicular or germ cell cancer. Primary mediastinal and retroperitoneal GCT are allowed. Seminoma and non-seminoma histologies are allowed.
Performance Status (PS) of ECOG 0-2 at the time of enrollment
Disqualifiers
Receiving chemotherapy in adjuvant setting
Prior VTE/PE
Currently taking anticoagulation or antiplatelet therapy. Non-steroidal anti-inflammatory drug (NSAID) use for pain is allowed
Prior indication for anticoagulation or anticoagulation contraindicated (e.g., active bleed or risk of bleeding, such as history of gastrointestinal ulcers)
Trial design
Treatments tested in this trial
- Low-dose ASA
Treatment groups
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator