A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Venous thromboembolism (VTE)-free
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Low-dose ASA (Drug)
结局指标
主要结局
Venous thromboembolism (VTE)-free
时间窗: 26 weeks after initiation of standard chemotherapy
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.
次要结局
- 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)