NCT07076186招募中2 期
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
To find out if receiving standard chemotherapy (doxorubicin and trabectedin) can extend the cancer-free survival of patients with Stage 1b/2 uterine leiomyosarcoma who had surgery that fully removed the tumor.
详细描述
Primary Objective:
To evaluate disease-free survival (DFS) in patients with FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
Secondary Objectives:
To assess overall survival (OS) in patients with FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
- To characterize treatment-related toxicity according to Common Terminology Criteria for Adverse Events (CTCAE), in patients with FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
- To evaluate quality of life (QoL) outcomes using patient-reported measures in patients with FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
- To analyze ctDNA dynamics as a predictor of treatment response and recurrence risk, in patients with FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
- To estimate the incidence of germline genetic alterations in patients with localized uLMS
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed uterine leiomyosarcoma
- •Patients must have localized tumors, AJCC stages 1b to 3 according to the AJCC uterine sarcoma staging system (high risk of relapse population)
- •Patients must have had complete surgical resection of tumor within 3 months prior to initiation of adjuvant chemotherapy, complete surgical resection includes at least a total hysterectomy
- •Patients must have no evidence of residual disease, as proven by CT Chest-Abdomen-Pelvic within 28 days before randomization (exclude potential metastatic patients)
- •Patients must have no history of pelvic radiation (hematologic tolerance of chemotherapy is impaired by pelvic radiation)
- •No prior chemotherapy for the treatment of the uterine leiomyosarcoma
- •Age ≥18 years. Because no dosing or adverse event data are currently available on the use of doxorubicin in combination with trabectedin in patients <18 years of age, children are excluded from this study.
- •ECOG performance status ≤2 (Karnofsky ≥60%,).
- •Patients must have adequate organ and marrow function as defined below:
- •absolute neutrophil count ≥1,000/mcL
- •platelets ≥100,000/mcL
- •total bilirubin ≤ institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
- •AST(SGOT)/ALT(SGPT) ≤2× institutional ULN
- •eGFR (using 2021 CKD-EPI) ≥40mL/min/1.73m2
- •Albumin > 28 g/L
- •CPK ≤2× institutional ULN
- •No cardiac dysfunction as proven by LVEF>50%
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- •Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who are receiving any other investigational agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or trabectedin or other agents used in study.
- •Patients with uncontrolled intercurrent illness per clinical judgment of the study PI and/or treating physician
- •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Phase II Single Arm Treatment with Doxorubicin and Trabectedin
Experimental
Participants will receive treatment on an outpatient and standard of care basis
干预措施: Trabectedin (Drug)
Phase II Single Arm Treatment with Doxorubicin and Trabectedin
Experimental
Participants will receive treatment on an outpatient and standard of care basis
干预措施: Doxorubicin Hydrochloride (Drug)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (3)
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