A Study of SBRT for OligoMetastatic ESCC
2021年1月24日 更新者:Kuai Le Zhao, MD、Fudan University
A Phase 2 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastatic Esophageal Squamous Cell Carcinoma
The aim of this phase II trial is to assess progress-free survival, local control, overall survival, safety and tolerability of SBRT to treat patients with oligometastases in esophageal squamous cell carcinoma.
研究概览
研究类型
介入性
注册 (实际的)
34
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200032
- Fudan Universtiy Shanghai Cancer Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with metastatic esophageal squamous cell carcinoma who have received initial treatment for the primary site including surgery or chemoradiotherapy. Primary tumor site without progression at registration. The sites of allowed metastases are: peripheral lung, central lung, medistinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic lymph node. All metastases not resected must be amenable to SBRT.
- 1-4 radiographically distinct metastases of any distribution in 2 or less allowed anatomical sites. The diameters of lesions should be less than or equal to 5cm.
- Initial treatment should be completed at least 3 months prior to study registration.
- All the metastases treated with SBRT should not be treated with surgery, radiation, radio frequency ablation or other regional therapeutic modalities prior to study registration. The other (s) lesions should have been surgically removed.
- Age ≥ 18. PS ECOG 0-2,wight loss<30% during the latest 6 months.
- Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
- Patient must provide study specific informed consent prior to study entry.
- For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.
Exclusion Criteria:
- Progression of primary tumor site at time of registration.
- Metastases with indistinct borders making targeting not feasible.
- Known brain metastases.
- Prior palliative radiotherapy to metastases.
Metastases located within 3 cm of the previously irradiated structures:
a).Spinal cord previously irradiated >80Gy(Biological equivalent dose with α/β=2), b).Brachial plexus previously irradiated to > 100Gy(Biological equivalent dose with α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to > 90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
- Drug addiction,Alcoholism or AIDS.
- Patients with severe organ dysfunction or Acute bacterial or fungal infection who are considered not suitable to enroll the study at the time of registration.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 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:Experimental Arm
Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.
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Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT.
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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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Progression-free survival
大体时间:The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
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progression-free survival will be measured as time to either progression or death
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The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
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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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Local control
大体时间:the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
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Local control will be measured as time to local recurrence
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the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
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overall survival
大体时间:The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.
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Overall survival will be measured as time until death from any cause
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The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Kuaile Zhao, MD.、Fudan Universtiy Shanghai Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年4月1日
初级完成 (实际的)
2018年12月1日
研究完成 (实际的)
2020年12月1日
研究注册日期
首次提交
2016年12月18日
首先提交符合 QC 标准的
2016年12月18日
首次发布 (估计)
2016年12月22日
研究记录更新
最后更新发布 (实际的)
2021年1月26日
上次提交的符合 QC 标准的更新
2021年1月24日
最后验证
2021年1月1日
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.
Esophageal Squamous Cell Carcinoma Metastatic的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌(MeSH术语:Carcinoma, Non-Small-Cell Lung) | 药物相关副作用和不良反应(MeSH术语) | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤(皮肤癌) | 非小细胞肺癌(MeSH术语:Carcinoma, Non-Small-Cell Lung)意大利
SBRT的临床试验
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Universitat de les Illes Balears邀请报名
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Soonchunhyang University HospitalSMG-SNU Boramae Medical Center尚未招聘肿瘤 | 继发性恶性肿瘤
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Kantonsspital Winterthur KSWKrebsforschung Schweiz, Bern, Switzerland招聘中