NCT02188615

Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chengchu Zhu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Squamous Cell Esophageal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE	Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
DRUG	Cisplatin	only Radical Chemoradiotherapy
DEVICE	Mckeown MIE	only Mckeown MIE using thoracoscopy and laparoscopy

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-06-01
• Completion: 2019-07-01
• First posted: 2014-07-11
• Last updated: 2014-07-11

Locations

1 site across 1 country: China