Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)
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
- 是
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
adjuvant radiotherapy is developed in this arm
干预措施: radiation (Radiation)
surgery alone
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
Jiaqing Xiang
Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
Fudan University
