NCT06866964 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Germ Cell Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2025-08-28 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Landon Brown, MD
PRINCIPAL INVESTIGATOR
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06866964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Germ Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06866964 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06866964 currently recruiting?
Yes, NCT06866964 is actively recruiting participants. Contact the research team at margarita.dzhanumova@advocatehealth.org for enrollment information.
Where is the NCT06866964 trial being conducted?
This trial is being conducted at Charlotte, United States, Winston-Salem, United States, Milwaukee, United States.
Who is sponsoring the NCT06866964 clinical trial?
NCT06866964 is sponsored by Wake Forest University Health Sciences. The principal investigator is Landon Brown, MD at Atrium Health Wake Forest Baptist Comprehensive Cancer Center. The trial plans to enroll 35 participants.