NCT04235660终止不适用
Yttrium-90 Radiation Segmentectomy Versus Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Early Stage Hepatocellular Carcinoma (HCC): A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment (Recruitment Rate)
研究概览
简要总结
The proposed study is a single site, prospective, randomized pilot study to assess the feasibility of recruitment of patients into a trial evaluating the efficacy and tolerability of selective transarterial Y90 radioembolization (radiation segmentectomy) versus stereotactic body radiation therapy (SBRT) for solitary early stage (≤ 3cm) hepatocellular carcinoma (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Radiologist assessing response will be blinded to the treatment type
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and HIPAA authorization
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥ 18 years at time of informed consent
- •Solitary HCC (≤3 cm) diagnosed by imaging (LI-RADS 4-5) or histology
- •Childs-Pugh score ≤ 7
- •ECOG performance status 0-1
- •Tumor location/characteristics eligible for either SBRT or Y90 therapy as deemed by local tumor board
- •Adequate organ function defined as:
- •serum bilirubin < 4.0 mg/dL ,
- •albumin > 2 g/dL
排除标准
- •Any prior locoregional therapy to the target tumor
- •Any prior radiation therapy to the liver
- •Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
- •i. Has undergone a hysterectomy or bilateral oophorectomy; or ii. Has been naturally amenorrheic for at least 24 consecutive months
- •Known severe allergic reaction (anaphylaxis) to iodinated contrast
- •Coagulopathy (platelets < 50 K/mm3 and/or INR > 2) not correctable by transfusion
- •Macrovascular invasion or extrahepatic HCC
结局指标
主要结局
Feasibility of Recruitment (Recruitment Rate)
时间窗: 24 months
Feasibility of recruitment will be measured by evaluating the proportion of patients enrolled versus those approached for the study after they have been determined to be a candidate.
次要结局
- Proportion of Patients With Any Toxicities(16 months for the first subject and 4 months for the second)
- Mean Change in Hepatobiliary Function(16 months for the first subject and 4 months for the second)
- Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score(6 months)
- Mean Change in Comprehensive Score for Financial Toxicity(6 months)
- Disease-free Survival (DFS) Rates of RS and SBRT(16 months for the first subject and 4 months for the second)
- Time-to-secondary Treatment (TTST) Between RS and SBRT(16 months for the first subject and 4 months for the second)
- Objective Response Rate(6 months)
研究者
Paul Haste
Assistant Professor of Clinical Radiology & Imaging Sciences
Indiana University
研究点 (2)
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