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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
only Radical Chemoradiotherapy
only Mckeown MIE using thoracoscopy and laparoscopy
Thaizhou Hospital
Linhai, Zhejiang, China
RECRUITINGOverall survival rate
Time frame: 1 years
Disease free survival
Time frame: 5years
Overall survival rate
Time frame: 3years
Overall survival rate
Time frame: 5years
the opportunity of MIE after neo-adjuvant chemoradiotherapy
Criteria:Response Evaluation Criteria in Solid Tumors,RECIST
Time frame: 4 weeks after completion of radiotherapy
Side effects of neo-adjuvant chemoradiotherapy
Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0
Time frame: 2 weeks after completion of radiotherapy
Duration of surgery
The time between the start of surgery until the end of surgery
Time frame: Intraoperative
Quantity of bleeding
The amount of bleeding during surgery
Time frame: Intraoperative
number of lymph nodes retrieved
The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area
Time frame: Intraoperative
Days of postoperative stay
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Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days
Time frame: The duration of hospital stay after surgery, an expected average of 12 days
Rate of Operative Complication
Time frame: 30 days after surgery
Mortality of perioperation
Time frame: 30 days after surgery