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S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

2017年6月14日 更新者：Xiaobo Du、Mianyang Central Hospital

Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma

Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy.

Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.

研究概览

地位

未知

条件

干预/治疗

详细说明

Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:

Experimental group: radiotherapy combined with S-1 chemotherapy;

control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.

Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.

Primary Outcome Measure is complete remission rate.

Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.

研究类型

介入性

注册 (预期的)

88

阶段

  • 阶段2

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。

学习联系方式

研究联系人备份

  • 姓名：Xue W Y, Student
  • 电话号码：+8615181958867
  • 邮箱：532995900@qq.com

学习地点

  • 中国
    • Sichaung
      • Mianyang、Sichaung、中国、621000
        • 招聘中
        • Xiaobo du
        • 接触：

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

不超过 75年 (孩子、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:

  1. Histology or cytology confirmed esophageal squamous cell carcinoma.
  2. There are measurable lesions in the RECIST standard.
  3. American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a~ IV B period.
  4. Age younger than 75 years old.
  5. Eastern Cooperative Oncology Group physical status score was 0 ~ 1.
  6. No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion.
  7. Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before.
  8. Serum hemoglobin is<100g/L, platelet>100 * 109/L,Absolute neutrophil count>1.5 * 109/L.
  9. Cr≤1.25 upper normal limit or CCr≥60 mL/min.
  10. Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit.
  11. A history of interstitial pneumonia and interstitial pneumonia.
  12. FEV1>0.8 liters.
  13. Patients or family members signed a formal informed consent.

Exclusion Criteria:

  1. Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
  2. Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
  3. Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
  4. Patients with distant metastases.
  5. There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
  6. Can't understand the test requirements, or patients may not comply with the requirements of the test.
  7. There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years.
  8. An allergic reaction known to have 3 or 4 levels of any treatment.
  9. Had participated in other clinical trials in the past 30 days.
  10. The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.

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：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
实验性的：Single drug
S-1 concurrent Radiotherapy
其他：S-1 concurrent radiotherapy
Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle.
有源比较器：Double drug
S-1 plus cisplatin concurrent Radiotherapy
其他：S-1 plus Cisplatin concurrent radiotherapy
Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.

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
Complete Remission Rate (CR)
大体时间：Three months after radiotherapy finished
Complete response rate of primary tumor which will be measured by endoscopy and computer tomography
Three months after radiotherapy finished

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Two years after adjuvant chemotherapy finished
The time from treatment completion to patient death
Two years after adjuvant chemotherapy finished
Progression-Free-Survival (PFS)
大体时间：Two years after adjuvant chemotherapy finished
The time from treatment completion to disease progression
Two years after adjuvant chemotherapy finished

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。

赞助

Mianyang Central Hospital

调查人员

  • 首席研究员：Bo Du X, Doctor、Mianyang Central Hospital

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。

一般刊物

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

2016年9月1日

初级完成 (预期的)

2019年3月1日

研究完成 (预期的)

2019年3月1日

研究注册日期

首次提交

2016年9月20日

首先提交符合 QC 标准的

2016年9月22日

首次发布 (估计)

2016年9月23日

研究记录更新

最后更新发布 (实际的)

2017年6月16日

上次提交的符合 QC 标准的更新

2017年6月14日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • XDu

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

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.

S-1 concurrent radiotherapy的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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