Possibilities for Improvement of an Outcome of the Treatment in Squamous Cell Carcinoma of the Thoracic Esophagus - a Multicenter Randomized Clinical Phase III Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- mean, median, 1-year, 3-year, 5-year overall survival
研究概览
简要总结
The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.
详细描述
The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
- •Patients' age above 18 years
- •General condition with Karnofsky performance status of >70
- •Circulatory and pulmonary capacity at normal range (FEV1 >60%; FVC >60%, NYHA I-II, cardiac output >40%)
- •Normal function of the bone marrow (RBC >3,5 T/l; PLT >100 G/l)
- •Normal renal (creatinine <1.5 of the upper limit) and liver (AST or ALT <2,5 of the upper limit or bilirubin <1,5 of the upper limit) function
排除标准
- •Metastatic disease
- •Synchronous malignancy
- •History of other cancer within 5 years prior to esophageal cancer treatment
- •History of allergic reaction to cisplatin of 5-fluorouracil
- •Systemic infection
- •Pregnancy or female patients in childbearing age without proper contraceptives.
研究组 & 干预措施
S
esophagectomy
干预措施: transthoracic esophagectomy 2-field extended lymphadenectomy (Procedure)
CHTS
neoadjuvant chemotherapy followed by esophagectomy
干预措施: neoadjuvant chemotherapy (cisplatin, 5-fluorouracil) (Drug)
CHRTS
neoadjuvant chemoradiotherapy followed by esophagectomy
干预措施: neoadjuvant chemoradiotherapy (Radiation)
结局指标
主要结局
mean, median, 1-year, 3-year, 5-year overall survival
时间窗: 5 years
次要结局
- toxicity-related morbidity and mortality(30-day)
- postoperative morbidity and mortality(30-day)
- clinical and pathological response rates(60-day)
- curative resection rate(30-day)