Squamous Cell Esophageal Carcinoma Clinical Trial
Official title:
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
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05357846 -
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
|
Phase 3 | |
| Active, not recruiting |
NCT01216527 -
Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
|
Phase 3 |