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Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

2019-10-28 13:57:15 | BioPortfolio

Summary

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

Description

Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.

The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.

The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.

The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.

The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.

Study Design

Conditions

Esophageal Cancer

Intervention

esophagectomy, chemoradiation, active surveillance

Location

The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
China
JX 791

Status

Recruiting

Source

Shanghai Chest Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-28T13:57:15-0400

Clinical Trials [1941 Associated Clinical Trials listed on BioPortfolio]

Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer – Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)

A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.

Surgery or Chemoradiation for Esophageal Cancer

The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).

Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer

The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiat...

Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the ad...

Mediastinoscopy-assisted Transhiatal Esophagectomy VS Minimally Invasive Esophagectomy for Esophageal Cancer

Esophageal cancer is the sixth leading cause of cancer-related death worldwide. Although the incidence of esophageal cancer has been decreased significantly in the past two decades in Chin...

PubMed Articles [19863 Associated PubMed Articles listed on BioPortfolio]

Comparing Perioperative Mortality and Morbidity of Minimally Invasive Esophagectomy Versus Open Esophagectomy for Esophageal Cancer: A Nationwide Retrospective Analysis.

We compared the surgical outcomes of minimally invasive esophagectomy (MIE) and open esophagectomy (OE) for esophageal cancer.

Diaphragmatic hernia following esophagectomy for esophageal cancer: A systematic review.

Diaphragmatic hernia following an esophagectomy for esophageal cancer (EC) can be both an early and late complication. The esophageal hiatus within the diaphragm is disrupted during the operation. How...

Illuminated Transhiatal Retractor for Mediastinal Dissection during Transhiatal Esophagectomy.

Esophagectomy following preoperative chemoradiation provides the best outcomes in the treatment of early-stage esophageal carcinoma. The exposure of the mediastinum during transhiatal esophagectomy is...

Minimally Invasive Esophagectomy.

Minimally invasive esophagectomy (MIE) was introduced in the 1990s with the aim to decrease the rate of respiratory complications associated with thoracotomy, along with the benefits of reduced morbid...

Current status of radiotherapy for patients with thoracic esophageal cancer in Japan, based on the Comprehensive Registry of Esophageal Cancer in Japan from 2009 to 2011 by the Japan Esophageal Society.

Although esophagectomy is the standard treatment for resectable esophageal cancer, chemoradiotherapy or radiotherapy alone is also selected for some cases. However, there have been very few detailed s...

Medical and Biotech [MESH] Definitions

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

Tumors or cancer of the ESOPHAGUS.

Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.

A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.

Surgical incision of the lower esophageal sphincter near the CARDIA often used to treat ESOPHAGEAL ACHALASIA.

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