Esophagectomy: Three-field Lymphadenectomy Versus. Two-field Lymphadenectomy for Thoracic Middle and Lower Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2002. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. Lymph node metastasis is one of the most important factors in predicting the prognosis of patients with esophageal carcinoma, but the extent of lymph node dissection is still in debate, and there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal extent of lymphadenectomy for esophageal cancer. The purpose of this study is to test two different extents of lymphadenectomy (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one extent of lymphadenectomy is superior than the other with better long-term outcome and acceptable postoperative short-term outcome or not.
详细描述
Background :
Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. The international Society for Diseases of the Esophagus has classified the extent of lymphadenectomy as standard, extended, total, and three-field lymphadenectomy. However, lymph node metastases can be present as regional metastasis, skip metastasis and distant metastasis, the optimal extent of lymphadenectomy remains controversial by now. Three-filed lymphadenectomy was criticized for higher surgical risks, but have the merits of removing all potential positive nodes and reducing the local recurrence. The purpose of this study is to conduct a large scale prospective randomized Phase Ⅲ clinical trial to test that based on the long-term outcomes(overall survival and disease free survival )and postoperative short-term outcomes(mortality, morbidity),whether one extent of lymphadenectomy is superior than the other approach or not.
Objectives:
- To compare overall survival after three-field lymphadenectomy and two-field lymphadenectomy
- To compare locoregional recurrence, disease free survival after three-field lymphadenectomy and two-field lymphadenectomy
- To compare postoperative morbidity and mortality in the two groups
Design: Prospective randomized controlled Setting: Fudan University Cancer Center, Shanghai, China. Patients and methods : All patients with biopsy proven carcinoma of the middle or lower third of the esophagus presenting to our hospital will be considered for the study.
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
- •Patients with histologically proven squamous cell esophageal cancer
- •Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans.
- •Karnofsky performance status greater than or equal to 80%
- •Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
- •Acceptable hepatic, renal and bone marrow function
排除标准
- •Patients with low performance status(Karnofsky score <80%)
- •Past history of malignancy
- •Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b)
- •Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- •Patients medically unfit for surgical resection
- •Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- •Patients with a significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
- •Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
- •Significant psychiatric illness that would interfere with patient compliance
- •Patients with severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
- •Patients considered of salvage surgery after definitive chemoradiotherapy
- •Patients after neoadjuvant chemoradiotherapy
- •Patients above the age of 75 years
- •Patients unreliable for follow up
结局指标
主要结局
Overall survival
时间窗: 3 years.
Participants will be seen at regular interval of 3 months the first year and every 6 months until death or the 3rd year.
次要结局
- Disease free survival(3 years)
研究者
Haiquan Chen
Fudan University cancer hospital, Fudan University cancer hospital
Fudan University