Radioembolization Versus External Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Rate of re-treatment over 12 months
研究概览
简要总结
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
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
- None
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
- •No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
- •Childs-Pugh score ≤ 8
- •ECOG performance status ≤2
- •Adequate organ function defined as:
- •serum bilirubin < 4.0 mg/dL ,
- •albumin > 2 g/dL
排除标准
- •Any prior SBRT or radioembolization to the target tumor
- •Macrovascular invasion
- •Planned or recommended systemic therapy as consolidation
- •Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.
- •Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy
研究组 & 干预措施
TARE
The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.
干预措施: Transarterial Radioembolization (Radiation)
SBRT
The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Rate of re-treatment over 12 months
时间窗: From enrollment to 12 months following the end of treatment
Rate of re-treatment of the index lesion over 12 months
次要结局
- Laboratory toxicities CBC(From enrollment to 24 months post treatment)
- Laboratory toxicities CMP(From enrollment to 24 months post treatment)
- Laboratory toxicities INR(From enrollment to 24 months post treatment)
- Laboratory toxicities AFP(From enrollment to 24 months post treatment)
- Clinical toxicities(From enrollment to 24 months post treatment)
- Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.(From enrollment to 1, 3, and 6 months post treatment)
- Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.(From enrollment to 1, 3, and 6 months post treatment)
- Disease Free Survival(From enrollment to 24 months post treatment)
- Local Control(From enrollment to 6 months post treatment)
- Overall Survival(From enrollment to 24 months post treatment)
研究者
Reena Salgia
Principal Investigator
Henry Ford Health System