Phase II Trial of Low-Dose Aspirin to Prevent Blood Clots in Adults with Advanced Germ Cell Tumors Receiving Chemotherapy

What this Trial Is About

Researchers are studying adults with advanced germ cell cancer who are at high risk for venous thromboembolism VTE. The study aims to evaluate the rate of participants who remain free of VTE for six months while receiving standard cisplatin-based chemotherapy combined with low-dose aspirin acetylsalicylic acid, ASA, comparing outcomes to historical data. This is a single-arm Phase II trial involving participants with stage IS or IIA or higher testicular or germ cell cancer. Participants will take a fixed low dose of aspirin 81 mg orally every day for 26 weeks alongside their standard chemotherapy. The study is designed in two stages first enrolling 13 participants, with expansion to a total of 31 if initial results show promising VTE prevention. Participants provide their own aspirin supply and will stop aspirin if they experience a VTE, switching to standard anticoagulation therapy as directed by their doctors. During the study, participants will be monitored for VTE events and bleeding risks over 26 weeks. Researchers will also assess relapse-free survival and overall survival up to two years after starting chemotherapy. Participants must be able to swallow oral medications and comply with study procedures throughout the treatment period. This study is sponsored by Wake Forest University Health Sciences and may include additional sites beyond the initial center.

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