A Single Institution Prospective Randomized Controlled Clinical Trial of Neo-adjuvant Chemoradiotherapy Followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE for Locally Advanced Squamous Cell Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.
详细描述
Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection remains the primary treatment for localized esophageal cancer. It increases the chances of cure and alleviates the symptoms of dysphagia compared with nonoperative methods. Advances in surgical techniques and equipments have made minimally invasive esophagectomy (MIE) more popular and wider application since 1990s. During the past two decades, MIE has progressively been accepted as an alternative treatment for esophageal cancer around the world. The prognosis has some improvement on account of these significant advances in surgical techniques and perioperative management, But the prognosis of patients with locally advanced esophageal cancer remains rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. It should be noticed that only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2 years, which may be not perfect to evaluate the effect of this combined therapy for this tumor type.
Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy. Then we are to carry out a clinical trial to investigate the effect of this multidisciplinary therapy, by comparing neo-adjuvant chemoradiotherapy followed by Mckeown MIE versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal 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
- Single (Outcomes Assessor)
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
- •Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
- •Patients must not have received any prior anticancer therapy.
- •More than 6 months of expected survival.
- •Age ranges from 18 to 70 years.
- •Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- •Karnofsky performance status (KPS) of 90 or more.
- •Signed informed consent document on file.
排除标准
- •Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
- •Patients with concomitant hemorrhagic disease.
- •Pregnant or breast feeding.
- •Inability to use gastric conduit after esophagectomy because of a prior surgery.
- •Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
- •Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
研究组 & 干预措施
experimental group
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
干预措施: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE (Procedure)
Radical Chemoradiotherapy
only Radical Chemoradiotherapy
干预措施: Cisplatin (Drug)
Mckeown MIE
only Mckeown MIE
干预措施: Mckeown MIE (Device)
结局指标
主要结局
Overall survival rate
时间窗: 5years
Disease free survival
时间窗: 5years
次要结局
- Side effects of neo-adjuvant chemoradiotherapy(2 weeks after completion of radiotherapy)
- the opportunity of MIE after neo-adjuvant chemoradiotherapy(4 weeks after completion of radiotherapy)
- Days of postoperative stay(The duration of hospital stay after surgery, an expected average of 12 days)
- Mortality of perioperation(30 days after surgery)
- Rate of Operative Complication(30 days after surgery)
- Duration of surgery(Intraoperative)
- Quantity of bleeding(Intraoperative)
- number of lymph nodes retrieved(Intraoperative)
研究者
Chengchu Zhu
Division Director
Taizhou Hospital