An Open-Label Randomized Clinical Trial to Evaluate the Efficacy of Neoadjuvant Chemoradiotherapy in Comparison With Neoadjuvant Chemotherapy in Patients With Resectable Squamous Cell Esophageal Cancer cT3-4aN0M0, cT1-4aN1-3M0.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to evaluate the safety, feasibility and outcomes of neoadjuvant chemotherapy followed by esophagectomy versus neoadjuvant chemoradiotherapy followed by esophagectomy for locally advanced resectable esophageal squamous cell carcinoma cT3-4aN0M0, cT1-4aN1-3M0. This is non-inferiority study (neoadjuvant chemoradiotherapy has no advantage over neoadjuvant chemotherapy).
详细描述
It is a prospective open-label randomized phase III clinical trial sponsored by N.N. Blokhin NMRC of Oncology. 156 patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0M0, cT1-4aN1-3M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (nCRT) followed by esophagectomy and the neoadjuvant chemotherapy group (nCT) followed by esophagectomy according to the proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are compared between the two regimens.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Histologically confirmed squamous cell carcinoma of the esophagus.
- •Clinical stage cT1-4aN1-3M0 (AJCC/UICC 8th Edition).
- •Indications for surgical esophageal resection
- •ECOG status 0-
- •Adequate bone marrow function (White Blood Cells > 3.0 x 109/L; Neutrophil > 2.0 × 109/L; Hemoglobin > 90 g/L; Platelets > 100 x 109/L).
- •Adequate liver function (Total bilirubin < 1.5 x Upper Level of Normal (ULN); Aspartate transaminase (AST) and Alanine transaminase (ALT) < 3.0 x ULN);
- •Adequate renal function (Glomerular filtration rate (CCr) > 50 ml/min.
- •Adequate cardiac function. Left ventricular ejection fraction > 50%.
- •Age from 18 years to 70
排除标准
- •Clinical stage cT4bcN0cM0 (AJCC/UICC 8th Edition).
- •Patients with advanced non-operable or metastatic esophageal cancer.
- •Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy.
- •Patients with another previous or current malignant disease.
- •Allergy or contraindications to Paclitaxel, Carboplatin, Docetaxel, Cisplatin or Fluoruracil.
- •Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive.
- •Severe concomitant diseases (uncontrolled arterial hypertension, diabetes mellitus, stroke less than 6 months old, mental disorders, other tumors, etc.).
- •Clinically significant coronary artery disease (NYHA III / IV), congestive heart failure (NYHAIII / IV), clinically significant cardiomyopathy, myocardial infarction within the last 6 months, or high risk of uncontrolled arrhythmia.
- •Chronic inflammatory diseases of the gastrointestinal tract
- •Acute infectious diseases.
- •Pregnancy or breast feeding.
- •Serious concomitant physical and mental illness / abnormalities or territorial reasons that may prevent the patient from participating in the protocol and adherence to the protocol schedule.
- •Foreigners or persons with limited legal rights.
- •Any medical, geographic, or social circumstance, that in the opinion of the investigator excludes the patient's participation in the protocol.
结局指标
主要结局
Disease-free survival
时间窗: 3(5) years after last patient enrolled
Survival without local or systemic recurrence
次要结局
- Treatment related complications(During the procedure)
- Number of cycles, frequency of neoadjuvant therapy reduction(During the procedure)
- Correlation between genetic profile and tumor response(Immediately after the procedure)
- Overall survival(3(5) years after last patient enrolled)
- Pathological response rate(pCR)(Immediately after the surgery)
- R0 resection rate(Immediately after the surgery)