Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma: A Missing Evidence and A Retrospective Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 826
- 试验地点
- 1
- 主要终点
- OS(overall survival)
研究概览
简要总结
Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. As the highest ESCC incidence area worldwid, we tried to analyze this top with big data by using a single-center case-control retrospective PMS study. Paclitaxel- and platinum-based NAC combined with two-field of the extensive mediastinal lymphadenectomy might provide better survival benefits than primary esophagectomy for stage II/III SCC.
详细描述
Treatment Neoadjuvant Chemotherapy Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1.
Surgical Procedure At approximately 6-8 weeks after NAC, open (McKeown, left thoracic incision left cervical anastomosis) or MIE via thoracoscopy and/or laparoscopy was performed in the patients. Bilateral laryngeal recurrent nerve lymph node dissection was requested for every patient.
Comparisons between the NAC and primary surgery groups were performed using the chi-square test, Mann-Whitney U test and Fisher's exact test for categorical parameters after PMS. Kaplan-Meier curves and a Cox proportional hazards regression model were adopted to perform OS analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018 and the data was prospectively collected in the hubble of the LinkDoc data company
- •Surgery performed in the thoracic surgery department
- •No previous cancer treatment
排除标准
- •Patients with secondary cancer were excluded
研究组 & 干预措施
Primary surgery group
The patients would receive primary surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. .
干预措施: Paclitaxel- and platinum-based chemotherapy (Drug)
结局指标
主要结局
OS(overall survival)
时间窗: From date of patient admission to the inpatient thoracic surgery department until the date of first documented death from any cause, assessed up to 100 months
OS was defined as the first date of patient admission to the inpatient thoracic surgery department to the date of death from any cause.
次要结局
- DFS(disease-free survival)(From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months)