Low-dose aspirin to prevent venous blood clots during chemotherapy for advanced germ cell (testicular) cancer

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

This trial will see if taking one daily low-dose aspirin (81 mg) during cisplatin chemotherapy prevents venous blood clots over six months in adults up to age 70 with high-risk advanced germ cell or testicular cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Charlotte, North Carolina and 2 other locations)
• Trial ID: NCT06866964 on ClinicalTrials.gov

What this trial studies

This single-arm, two-stage Phase II trial will enroll up to 31 adults with high-risk advanced germ cell or testicular cancer who are receiving standard cisplatin-based chemotherapy. Participants will self-administer 81 mg of aspirin daily for 26 weeks and the six-month VTE-free rate will be compared to relevant historical controls. Stage 1 enrolls 13 participants and will expand to Stage 2 (an additional 18 participants) if at least 9 of the first 13 remain free of VTE through 26 weeks. Participants who develop a VTE will stop aspirin and receive standard anticoagulation under their treating investigator's direction.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed stage IIC/III (or higher) germ cell or testicular cancer, ECOG performance status 0–2, identified as high risk for VTE and starting cisplatin-based chemotherapy fit the eligibility profile.

Not a fit: Patients already on therapeutic anticoagulation, those with aspirin contraindications (active bleeding or allergy), those at low VTE risk, or patients not receiving cisplatin-based chemotherapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, daily low-dose aspirin could lower the risk of chemotherapy-associated venous thrombosis in high-risk germ cell tumor patients, potentially reducing clot-related complications and hospital stays.

How similar studies have performed: Using low-dose aspirin specifically to prevent cancer-associated VTE is relatively novel and not well established, while anticoagulant drugs have been more commonly studied and used for VTE prevention in cancer patients.

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 criteria 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 criteria 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 score 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 10\^9/L iii. +1 point for hemoglobin \<10 g/dL iv. +1 point for leukocyte count \>11 x 10\^9/L v. +1 point for BMI \>35 kg/m\^2
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

Where this trial is running

Charlotte, North Carolina and 2 other locations

• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Charlotte, North Carolina, United States (Recruiting)
• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
• Aurora St. Luke's Medical Center MOB — Milwaukee, Wisconsin, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Landon Brown, MD — Atrium Health Wake Forest Baptist Comprehensive Cancer Center
• Study coordinator: Margarita Dzhanumova

Conditions Germ Cell Tumor; Testicular Cancer; cancer; Venous thromboembolism