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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

    • Shanghai
      • Shanghai、Shanghai、中国、200032
        • Fudan Universtiy Shanghai Cancer Center

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Initial treatment should be completed at least 3 months prior to study registration.
  4. 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.
  5. Age ≥ 18. PS ECOG 0-2,wight loss<30% during the latest 6 months.
  6. Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
  7. Patient must provide study specific informed consent prior to study entry.
  8. For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.

Exclusion Criteria:

  1. Progression of primary tumor site at time of registration.
  2. Metastases with indistinct borders making targeting not feasible.
  3. Known brain metastases.
  4. Prior palliative radiotherapy to metastases.
  5. 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.

  6. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
  7. Drug addiction,Alcoholism or AIDS.
  8. 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
实验性的:Experimental Arm
Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.
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.

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
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
progression-free survival will be measured as time to either progression or death
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

次要结果测量

结果测量
措施说明
大体时间
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.
Local control will be measured as time to local recurrence
the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
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.
Overall survival will be measured as time until death from any cause
The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.

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

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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

SBRT的临床试验

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