A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group
详细描述
Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.
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
- Single (Outcomes Assessor)
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
- •Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery.
- •T≥3 or N≥1, and more than 15 lymph nodes were dissected.
- •Age ≥18 years and ≤75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Adequate hematological function:
- •absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.
- •Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
- •Adequate renal function:
- •serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.
- •Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent
排除标准
- •Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study.
- •Serious postoperative complications that will affect progress of chemotherapy.
- •Patients with chemotherapy contraindications.
- •Women who are pregnant or breast-feeding or who are planning for pregnancy.
- •Unable to complete the follow-up as planned.
- •Without informed consent due to psychological, family, social and other factors.
研究组 & 干预措施
Experimental group
patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles
干预措施: chemotherapy (Drug)
结局指标
主要结局
Disease-free survival
时间窗: At most 5 years after enrollment
Patients were images with computed tomography (CT) scan
次要结局
- overall survival(At most 5 years after enrollment)
研究者
Peng Lin
Clinical Professor
Sun Yat-sen University