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
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
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)
Single group
Low-dose ASA
Drug81 mg by mouth daily for 26 weeks
Venous thromboembolism (VTE)-free
A binary variable indicating whether the participant had zero VTE events within 26 weeks of initiation of standard chemotherapy. VTE events include objectively confirmed symptomatic or asymptomatic proximal deep-vein thrombosis in a lower limb, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, symptomatic or incidental pulmonary embolism, symptomatic or incidental central catheter related thrombosis, or death from venous thromboembolism.
Major Bleeding Event
A categorical variable indicating whether the participant experienced a major bleeding event within 26 weeks of initiation of standard chemotherapy. A major bleeding event is defined by the occurrence of at least one of the following. Bleeding associated with death. Overt bleeding and associated with a decrease from baseline in hemoglobin concentration by at least 2.0 g/L or with the need for transfusion of ≥ 2 units of whole blood or red cells. Bleeding in a critical area or organ such as retroperitoneal, intracranial, intraocular, intraspinal, intraarticular or pericardial, or intramuscular with compartment syndrome as determined by the investigator.
Clinically Relevant Non-Major Bleeding
A categorical variable indicating whether the participant experienced clinically relevant non-major bleeding within 26 weeks of initiation of standard chemotherapy. Clinically relevant non-major bleeding is defined as bleeding that leads to a medical intervention, an unscheduled contact with provider, temporary cessation of oral anticoagulants or antiplatelet agent, discomfort for the participant (such as pain) or impairment of activities of daily living.
Relapse-Free Survival (RFS)
Calculated from the date of enrollment to the date of first documented evidence of recurrent disease or death, whichever occurred first. For participants who have not relapsed, RFS will be censored at the last disease status assessment. Relapse will be determined by biopsy proven recurrent non-teratoma germ cell tumor, initiation of salvage chemotherapy, or rising tumor markers unequivocally.
Overall Survival (OS)
Calculated from the date of enrollment to the date of death from any cause. Participants who are alive or lost to follow up at the time of the final analysis will be censored at the last known date they were alive.
Febrile Neutropenia Event
A binary variable indicating whether the participant experienced a febrile neutropenia event deemed to be related to acetylsalicylic acid (ASA) treatment while receiving ASA treatment. Febrile neutropenia will be documented and graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator
