A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy
ASPIRE
3 other identifiers
interventional
35
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2025
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
February 2, 2026
January 1, 2026
3.9 years
March 4, 2025
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Venous thromboembolism (VTE)-free
A binary variable indicating whether the participant had zero VTE events within 26 weeks of initiation of standard chemotherapy. VTE events include objectively confirmed symptomatic or asymptomatic proximal deep-vein thrombosis in a lower limb, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, symptomatic or incidental pulmonary embolism, symptomatic or incidental central catheter related thrombosis, or death from venous thromboembolism.
26 weeks after initiation of standard chemotherapy
Secondary Outcomes (4)
Major Bleeding Event
26 weeks after initiation of standard chemotherapy
Clinically Relevant Non-Major Bleeding
26 weeks after initiation of standard chemotherapy
Relapse-Free Survival (RFS)
2 years after initiation of standard chemotherapy
Overall Survival (OS)
2 years after initiation of standard chemotherapy
Other Outcomes (1)
Febrile Neutropenia Event
26 weeks after initiation of standard chemotherapy
Study Arms (1)
Low-dose aspirin (acetylsalicylic acid [ASA])
EXPERIMENTALASA 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
81 mg by mouth daily for 26 weeks
Eligibility Criteria
You may qualify if:
- Written informed consent and 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 ECOG 0-2 at the time of enrollment
- 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
- 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
You may not qualify if:
- Receiving chemotherapy in adjuvant setting
- Prior VTE/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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Charlotte, North Carolina, 28204, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Aurora St. Luke's Medical Center MOB
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Landon Brown, MD
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 10, 2025
Study Start
August 28, 2025
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
January 1, 2031
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share