This phase II trial studies how well low-dose aspirin (ASA) works in preventing blood clots in the veins (venous thromboembolism [VTE]) in patients receiving chemotherapy for testicular cancer or germ cell tumors (GCTs) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients who are being treated with the type of chemotherapy used for testicular cancer and GCTs are at a higher risk of developing blood clots. Low-dose ASA contains a lower dose of ASA than a standard adult tablet, usually between 81 and 100mg. ASA in varying doses has been shown to reduce the blood clot rate in bone trauma, hip replacement, and multiple myeloma (a blood cancer) treatment. Low-dose ASA may be effective in preventing VTE in patients receiving chemotherapy for testicular cancer or advanced GCTs.
Additional locations may be listed on ClinicalTrials.gov for NCT06866964.
Locations matching your search criteria
United States
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer InstituteStatus: Active
Contact: Landon Carter Brown
Phone: 980-442-2536
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Michael McCormack
Phone: 336-713-5440
PRIMARY OBJECTIVE:
I. To evaluate the 6-month 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 ASA and compare to relevant historical controls.
SECONDARY OBJECTIVES:
I. Evaluate the major bleeding rate.
II. Evaluate the rate of clinically relevant non-major bleeding.
III. Evaluate relapse-free survival (RFS).
IV. Evaluate overall survival (OS).
EXPLORATORY OBJECTIVE:
I. To associate clinical risk factors of VTE including obesity (body mass index [BMI] > 30), large retroperitoneal lymphadenopathy (N3, > 5cm), lactate dehydrogenase (LDH) level, central venous catheter use, febrile neutropenia, cycles of chemotherapy, age, and Khorana score.
OUTLINE:
Patients receive low-dose ASA orally (PO) daily starting on day 1 of chemotherapy initiation and continuing for up to 26 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 2 years after initiation of front-line chemotherapy.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorLandon Carter Brown