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Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)

NCT04027543•Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.

Detailed Description

Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.
•Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography.
•Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria

•Patients had received any previous treatment for oesophageal cancer.
•Patients who were unsuitable for surgery because of comorbidities.
•Patients had evidence of distant metastatic disease by history and physical examination.

Locations (3)

Massachusetts General Hospital of Harvard Medical School

Boston, Massachusetts, United States

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

November 14, 2018

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

May 29, 2020

Enrollment

423

ACTUAL participants

Conditions

Radiotherapy Side EffectChemotherapy EffectOesophageal CarcinomaEffect of DrugsSafety Issues

Interventions

Neoadjuvant chemoradiotherapy

COMBINATION_PRODUCT

Oesophagectomy

PROCEDURE

Neoadjuvant chemotherapy

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

Inclusion Criteria

Exclusion Criteria

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