Recruiting
Phase 2

Cisplatin with ASA

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06866964

Conditions

Germ Cell Tumor

Testicular Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Low-dose ASA

Study Details

Brief summary:

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

Conditions

Germ Cell Tumor

Testicular Cancer

Study ID

NCT06866964

Start date

Aug 28, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Low-dose aspirin (acetylsalicylic acid [ASA])

ASA has been shown to reduce risk of VTE. It will be self-administered, a fixed dose of ASA (81 mg) by mouth daily for 26 weeks.

Interventions

Low-dose ASA

81 mg by mouth daily for 26 weeks

Primary outcome measure

  • Venous thromboembolism (VTE)-free [ Time Frame: 26 weeks after initiation of standard chemotherapy ]

Central Contacts and Locations

Central contacts

Locations

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Landon Brown, MD

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Michael McCormack, MD

Aurora St. Luke's Medical Center MOB

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Antony Ruggeri, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • cancer
  • Venous thromboembolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-24.