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

NCT ID: NCT06866964

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-28
• Study Completion Date: 2031-01-31

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

Detailed Description

This is a single-arm, two-stage, Phase II study designed to evaluate the 6-month 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 ASA as compared to relevant historical controls. Stage 1 will consist of 13 participants. If at least 9 of those 13 do not experience a VTE event during the first 26 weeks on the ASA, Stage 2 will be activated. Stage 2 will enroll an additional 18 participants for a total of 31. Participants will provide their own supply of ASA. Participants will self-administer a fixed dose of ASA (81 mg) by mouth daily for 26 weeks. Participants who experience the primary endpoint of VTE will stop ASA and start standard of care anticoagulation at the direction of the treating investigator. This study will initially open as a single center study at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) and additional investigational site(s) may be added following activation at the lead site.

Conditions

Germ Cell Tumor; Testicular Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-dose ASA

Intervention Type: DRUG

81 mg by mouth daily for 26 weeks

Interventions

Low-dose ASA

81 mg by mouth daily for 26 weeks

Intervention Type: DRUG

Other Intervention Names

aspirin

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrium Health Wake Forest Baptist

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Landon Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Locations

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Charlotte, North Carolina, United States

Site Status: RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Aurora St. Luke's Medical Center MOB

Milwaukee, Wisconsin, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Margarita Dzhanumova

Role: CONTACT

margarita.dzhanumova@advocatehealth.org

980-515-5300

Facility Contacts

Margarita Dzhanumova

Role: primary

margarita.dzhanumova@advocatehealth.org

980-515-5300

Michael McCormack, MD

Role: primary

mmccorma@wakehealth.edu

336-716-7975

Milanka Petrovic

Role: primary

milanka.petrovic@aah.org

414-649-5391

Other Identifiers

ONC-GU-2402

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00085150

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00126906

Identifier Type: -

Identifier Source: org_study_id