Low-Dose Aspirin for the Prevention of Venous Thromboembolism in Patients Receiving Chemotherapy for Testicular Cancer or Advanced Germ Cell Tumors, ASPIRE GCT Trial

Inclusion Criteria

• Written informed consent and Health Insurance Portability and Accountability Act (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 Eastern Cooperative Oncology Group (ECOG) 0-2 at the time of enrollment
• At least one of the following “high risk” of VTE features: * Stage IIC or III or higher per American Joint Committee on Cancer (AJCC) 8th edition criteria ** Stage IIC – any pT/TX, N3, M0, S0-1 ** Stage III – any pT/TX, any N, M1, SX ** Stage IIIA – any pT/TX, any N, M1a, S0-1 ** Stage IIIB – any pT/TX, N1-3, M0, S2 or any pT/TX, any N, M1a, S2 ** Stage IIIC – any pT/TX, N1-3, M0, S3 or any pT/TX, any N, M1a, S3 or any pT/TX, any N, M1b, any S *** Serum marker (S category): SX; S criteria: Marker studies not available or not performed *** Serum marker (S category): S0; S criteria: Marker study levels within normal limits *** Serum marker (S category): S1; S criteria: LDH < 1.5 × normal and human chorionic gonadotropin (hCG) < 5000 IU/L and alpha-fetoprotein (AFP) < 1000 ng/mL *** Serum marker (S category): S2; S criteria: LDH 1.5 to 10 × normal or hCG 5000 to 50,000 IU/L or AFP 1000 to 10,000 ng/mL *** Serum marker (S category): S3; S criteria: LDH > 10 × normal or hCG > 50,000 IU/L or AFP > 10,000 ng/mL * Intermediate or poor risk by International Germ Cell Cancer Collaborative Group (IGCCCG) criteria ** Intermediate risk – testis/retroperitoneal primary and no non-pulmonary visceral metastases plus at least one of the following markers: AFP > 1,000 ng/mL to ≤ 10,000 ng/mL, beta-hCG > 5,000 IU/L and ≤ 50,000 IU/L, LDH > 1.5 × normal and ≤ 10 × normal ** Poor risk – mediastinal primary or non-pulmonary visceral metastases plus at least one of the following markers: AFP > 10,000 ng/mL, beta-hCG > 50,000 IU/L, LDH > 10 × normal * Khorana score of 2 or higher ** +1 point for testicular/germ cell cancer (All patients will receive +1 for their testicular/germ cell cancer diagnosis. Thus, a patient with any other Khorana characteristic [ii-v] will meet this inclusion criteria.) ** +1 point for platelet ≥ 350 x 10^9/L ** +1 point for hemoglobin < 10 g/dL ** +1 point for leukocyte count > 11 x 10^9/L ** +1 point for BMI > 35 kg/m^2
• Planning or recently started 3-4 cycles of standard of care front-line cisplatin-based chemotherapy (bleomycin, etoposide, and platinum [BEP], etoposide and cisplatin [EP], or etoposide, ifosfamide, and cisplatin [VIP]). Note: ASA should be initiated no later than 2 weeks after initiation of standard front-line chemotherapy
• As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
• Ability to swallow oral medications

Exclusion Criteria

• Receiving chemotherapy in adjuvant setting
• Prior VTE/pulmonary embolism (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)
• Allergy to ASA