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Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer

2021年12月27日 更新者:Chuangzhen Chen

A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.

研究概览

地位

完全的

条件

详细说明

Esophageal cancer is one of the most common malignant diseases in China, especially in Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per fraction generally. However, although with such comprehensive method, noncontrol of local disease or recurrence is still the main reason of failure.

Most patients with esophageal cancer suffer from malnutrition. A number of factors including hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local failures of disease after treatment; therefore a higher radiation biological equivalent dose (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial had shown that simply increasing total radiation dose could not gain better local control or overall survival rate, however, the ability of this trial to test the potential benefits of higher radiation dose could be compromized by the deficiencies within them, such as, observation bias,large radiated target volume and usage of conventional radiation technique. In other words, the probability that increasing radiation may help improving the control of disease should not be denied.

Modern radiation techniques, such as intensity modulation radiation therapy (IMRT), specially, are able to improve the coverage of target volumes and sparing of critical structures, while increase the total radiation dose. By using simultaneous modulated accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per fraction could be reduced significantly, while the doses to tumor could be increased to higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with conventional technique.

Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late toxicities would be tolerable and slighter than that of conventional technique.

研究类型

介入性

注册 (实际的)

85

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。

学习地点

    • Guangdong
      • Shantou、Guangdong、中国、515031
        • Cancer Hospital, Shantou University Medical College

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 至 75年 (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:

  • pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
  • the primary disease located in cervical, upper or middle thoracic esophagus
  • no distant metastases
  • zubrod performance status: 0~2
  • life expectancy > 6 months; -absence of another malignancy
  • adequate liver, renal and bone marrow function
  • women of childbearing potential and male participants must practice adequate contraception
  • patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • evidence of tracheoesophageal or Mediastinal-esophageal fistula
  • prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
  • prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
  • pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • women who are nursing

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:SMART combined with PF chemotherpay
SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)
The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.
Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.
其他名称:
  • cisplatin plus 5fluorouracil

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
Toxicities
大体时间:The period during treatment and the 2 years after treatment
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs as assessed by CTCAE 4.0
The period during treatment and the 2 years after treatment

次要结果测量

结果测量
措施说明
大体时间
Local control rate
大体时间:2 years after treatment
The percentage of patients without locoregional tumor recurrence 2 years after treatment
2 years after treatment
overall survival rate
大体时间:2 years after treatment
The percentage of patients that are alive 2 years after treatment
2 years after treatment
Complete blood count
大体时间:before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)
The complete blood count as assessed by a Coulter (LH 750 Haematology Analyzer)
before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)

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

  • 首席研究员:Chuangzhen Chen, MD、Cancer Hospital, Shantou University Medical College

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

2012年8月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2012年8月12日

首先提交符合 QC 标准的

2012年8月19日

首次发布 (估计)

2012年8月22日

研究记录更新

最后更新发布 (实际的)

2022年1月3日

上次提交的符合 QC 标准的更新

2021年12月27日

最后验证

2021年12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.

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