Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 3
- 主要终点
- Overall survival (OS)
研究概览
简要总结
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
详细描述
Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.
- •Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography.
- •Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
排除标准
- •Patients had received any previous treatment for oesophageal cancer.
- •Patients who were unsuitable for surgery because of comorbidities.
- •Patients had evidence of distant metastatic disease by history and physical examination.
研究组 & 干预措施
Neoadjuvant chemoradiotherapy
Patients who had chemoradiotherapy before surgery.
干预措施: Neoadjuvant chemoradiotherapy (Combination Product)
Neoadjuvant chemotherapy
Patients who had chemotherapy before surgery.
干预措施: Neoadjuvant chemotherapy (Drug)
Surgery alone
Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.
干预措施: Oesophagectomy (Procedure)
结局指标
主要结局
Overall survival (OS)
时间窗: 5 years
The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.
次要结局
- R0 resection rate(Baseline)
- Disease-free survival (DFS)(5 years)
- Pathologic complete response (pCR)(Baseline)
- 30-day postoperative or in-hospital mortality(30 days)
研究者
Herui Yao
Principal Investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University