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临床试验/NCT03273647
NCT03273647尚未招募3 期

Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)

Fudan University0 个研究点目标入组 60 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
60
主要终点
Disease-free survival time

研究概览

简要总结

The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.

详细描述

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. In rectal cancer, the involvement of the circumferential resection margin (CRM) is one of the key factors for local recurrence and poor prognosis,based on reports in which CRM with < 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the CRM involvement in EC has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of CRM. There is lack of clear evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM) patients of TESCC now. In view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection Margin(CRM) for thoracic esophageal squamous cell carcinoma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 18 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+
  • KPS≥70 before radiotherapy;
  • Did not receive neoadjuvant or adjuvant treatment;
  • No clear recurrent or metastatic lesions before radiotherapy;
  • Intensity modulated radiation therapy(IMRT) is accepted;
  • Regular follow-up.

排除标准

  • Exploratory thoracotomy or palliative surgery;
  • No clear recurrent or metastatic sites;
  • Recurrence or metastasis is not certain;
  • death of no definite cause.
  • Irregular follow-up;

研究组 & 干预措施

surgery plus radiation

Experimental

adjuvant radiotherapy is developed in this arm

干预措施: radiation (Radiation)

surgery alone

No Intervention

No adjuvant radiotherapy,that is surgery alone is developed in this arm

结局指标

主要结局

Disease-free survival time

时间窗: up to 3 years

including survival time from randomization to locoregional recurrence and to distal metastasis

次要结局

  • overall survival time(up to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiaqing Xiang

Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center

Fudan University

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