Comparison of SBRTand Repeat TACE for HCC (STH)
Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial
研究概览
详细说明
The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.
In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Gangwondo
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Wŏnju、Gangwondo、大韩民国、25440
- 招聘中
- Gangneung Asan Hospital
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接触：
- Baek Gyu Jun, M.D
- 电话号码：82-10-5674-0712
- 邮箱：backyou78@hanmail.net
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接触：
- Gan Jin Cheon, M.D Ph.D.
- 电话号码：82-33-610-3018
- 邮箱：1000@gnah.co.kr
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age >18 years
- Eastern cooperative oncology group(ECOG) score 0 to 2
- Primary HCC
- HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
- Child-Turgottei-Pugh A or B
- Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
- No evidence of radiologically definable major vascular invasion or extrahepatic disease
- Previously incomplete TACE with radiologically defined residual disease after first TACE
- Informed consent
Exclusion Criteria:
- Prior TACE to the target lesion
- Contraindication to receiving radiotherapy or TACE
- Decompensated liver cirrhosis
- Extrahepatic mets
- Pregnancy
- Patients with other cancers
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SBRT (Stereotatic body radiotherapy)
Treatment of SBRT in HCC patients who have incomplete response after first TACE
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Maximum dose : 60Gray (Gy) Fraction : 2 to 5
其他名称：
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无干预：TACE (Transarterial chemoembolization)
Treatment of repeated TACE in HCC patients who have incomplete response after first TACE
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Local tumor control (efficacy fo SBRT)
大体时间：1 year
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To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. |
1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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progression free-survival
大体时间：2 year
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survival from SBRT to recurrence
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2 year
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overall survival
大体时间：2 year
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survival from SBRT to death
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2 year
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Radiation induced liver disease (RILD)
大体时间：1 year
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Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE). RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT. |
1 year
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合作者和调查者
调查人员
- 研究主任：Gab Jin Cheon, M.D, Ph. D、University of Ulsan College of Medicine, Gangneung Asan Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.