A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 4
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.
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
- 否
入选标准
- •biopsy-confirmed esophageal squamous cell carcinoma
- •age ≤ 70 years old,
- •Karnofsky performance status ≥ 70,
- •R0 esophagectomy according to the pathological examination of the resected specimens,
- •postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
- •Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin <1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1>0.8 L;.
- •no previous treatment or severe complications
- •Written informed consent
排除标准
- •previous treatment with chemotherapy or radiotherapy
- •greater than 3 months after surgery
- •complete esophageal obstruction after surgery, esophageal perforation;
- •other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- •pregnant or breast-feeding women；
- •patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease；
- •drug addiction, Alcoholism or AIDS;
- •uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- •with clear chemotherapy drug allergy
- •participation in other interventional clinical trials within 30 days;
研究组 & 干预措施
concurrent chemoradiotherapy group
All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
干预措施: Docetaxel plus cisplatin (Drug)
concurrent chemoradiotherapy group
All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
干预措施: radiotherapy (Radiation)
radiotherapy group
All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。
次要结局
- treatment-related toxicities(From the date of randomization until six months after treatment completion)
- Quality of life(QOL)(1 year)
- Overall survival (OS)(From date of randomization to death from any cause, assessed up to 3 years)