Esophageal Cancer Clinical Trial

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

Summary

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

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Full 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.

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Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

423

Study ID:

NCT04027543

Recruitment Status:

Completed

Sponsor:

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

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There are 2 Locations for this study

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Massachusetts General Hospital of Harvard Medical School
Boston Massachusetts, 01748, United States
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51000, China
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou Guangdong, 51000, China

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

423

Study ID:

NCT04027543

Recruitment Status:

Completed

Sponsor:


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

How clear is this clinincal trial information?

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