Comparison Between NCRT and NCT Followed by MIE for Treatment of Locally Advanced Resectable ESCC

Summary

The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).

Conditions

• Esophageal Squamous Cell Carcinoma Stage cT3-4aN0-1M0

Interventions

PROCEDURE

Neoadjuvant Chemoradiotherapy

Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.

PROCEDURE

Neoadjuvant Chemotherapy

Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.

PROCEDURE

Minimally Invasive Esophagectomy

After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy

Sponsors & Collaborators

• Fujian Medical University Union Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Changzhi Medical College

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Peking University Cancer Hospital and Institute

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Principal Investigators

• Lijie Tan, MD · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2019-02-28

Completion

2020-08-31

Countries

• China

Study Locations