Prospective Randomized Controlled Trial of Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 537
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).
详细描述
Esophageal squamous cell carcinoma (ESCC) is a common type of esophageal carcinoma in China, which is characterized by rapid development and fatal prognosis in most patients. Neoadjuvant chemoradiotherapy (nCRT) has been explored for many years in western countries and Japan, and proved to get survival benefit, especially for locally advanced esophageal cancer. However, the recurrence is the major cause of treatment failure in patients with ESCC. Our hypothesis is that inadequate radiation dose leads to recurrence of ESCC with nCRT and PORT lower recurrence rate and improved OS. As is known, there are no any studies concentrating on PORT in ESCC with nCRT. Patients are randomly assigned to PORT (Group A) or without PORT (Group B) with a 1:1 allocation ratio. The primary outcome is OS assessed with a minimum follow-up of 60 months. Secondary outcomes are progression-free survival (PFS), recurrence-free survival (RFS).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;
- •Tumors of the esophagus are located in the thoracic cavity;
- •Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
- •Male or non pregnant female
- •Age is between 18 years and 65 years,
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
- •Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
- •Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
- •Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
- •The patient has provided written informed consent and is able to understand and comply with the study.
排除标准
- •Patients with non-squamous cell carcinoma histology;
- •Patients with advanced inoperable or metastatic esophageal cancer;
- •Patients with another previous or current malignant disease；
- •Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
- •Age >65 years;
- •Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- •Patients who refuse surgery after neoadjuvant chemotherapy;
- •Unsuitable to be enrolled in the trial in the opinion of the investigators
研究组 & 干预措施
Group A
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
干预措施: Neoadjuvant chemotherapy Program (Drug)
Group A
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
干预措施: Postoperative radiotherapy program (Radiation)
Group B
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program
干预措施: Neoadjuvant chemotherapy Program (Drug)
结局指标
主要结局
overall survival
时间窗: From enrollment to 5 years after the end of treatment
The length of time from enrollment until the time of death
次要结局
- disease free survival(From enrollment to 5 years after the end of treatment)
- local recurrence rate(From enrollment to 5 years after the end of treatment)
- Side effects(From enrollment to 12 weeks after end of the treatment)
研究者
Benhua Xu
Director,Radiation Oncology
Fujian Medical University Union Hospital