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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a low dose of aspirin can help prevent blood clots in patients with advanced germ cell tumors, such as testicular cancer, who are undergoing chemotherapy. Blood clots, also known as venous thromboembolism (VTE), can be a serious risk for these patients, especially while receiving certain chemotherapy treatments. The goal is to see how many patients remain free of blood clots during the first six months of treatment compared to previous studies.

To participate in this trial, individuals must be between 18 and 70 years old and have a confirmed diagnosis of advanced testicular or germ cell cancer. They should also be starting a specific type of chemotherapy known as cisplatin-based chemotherapy. Participants will need to commit to taking aspirin as part of their treatment plan. It’s important to note that the trial is not yet recruiting participants, and those interested should talk to their healthcare provider for more information.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent and HIPAA authorization for release of personal health information
• • 2. Age ≥ 18 years and ≤ 70 years at the time of consent
• • 3. 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.
• • 4. Performance Status (PS) of ECOG 0-2 at the time of enrollment
• 5. At least one of the following "high risk" of VTE features:
• • a. Stage IIC or III or higher per AJCC 8th edition criteria15 i. Stage IIC - any pT/TX, N3, M0, S0-1 ii. Stage III - any pT/TX, any N, M1, SX iii. Stage IIIA - any pT/TX, any N, M1a, S0-1 iv. Stage IIIB - any pT/TX, N1-3, M0, S2 or any pT/TX, any N, M1a, S2 v. 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) S criteria SX Marker studies not available or not performed S0 Marker study levels within normal limits S1 LDH \< 1.5 x normal and hCG \< 5000 IU/L and AFP \<1000 ng/mL S2 LDH 1.5 to 10 x normal or hCG 5000 to 50,000 IU/L or AFP 1000 to 10,000 ng/mL S3 LDH \>10 x normal or hCG \>50,000 IU/L or AFP \>10,000 ng/mL
• • b. Intermediate or poor risk by IGCCCG criteria16 i. 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 x normal and ≤ 10 x normal ii. 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 x normal c. Khorana score17 of 2 or higher i. +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.) ii. +1 point for platelet ≥350 x 109/L iii. +1 point for hemoglobin \<10 g/dL iv. +1 point for leukocyte count \>11 x 109/L v. +1 point for BMI \>35 kg/m2
• • 6. 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.
• • 7. As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
• • 8. Ability to swallow oral medications
• Exclusion Criteria:
• • 1. Receiving chemotherapy in adjuvant setting
• • 2. Prior VTE/PE
• • 3. Currently taking anticoagulation or antiplatelet therapy. Non-steroidal anti-inflammatory drug (NSAID) use for pain is allowed
• • 4. Prior indication for anticoagulation or anticoagulation contraindicated (e.g., active bleed or risk of bleeding, such as history of gastrointestinal ulcers)
• • 5. Allergy to ASA