A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWake Forest University Health Sciences

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

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Wake Forest Baptist

Collaborator