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

Completed

• Conditions: Radiotherapy Side Effect; Chemotherapy Effect; Oesophageal Carcinoma; Effect of Drugs; Safety Issues
• Interventions: Combination Product: Neoadjuvant chemoradiotherapy; Drug: Neoadjuvant chemotherapy; Procedure: Oesophagectomy

• Registration Number: NCT04027543
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemoradiotherapy	Neoadjuvant chemoradiotherapy	Patients who had chemoradiotherapy before surgery.
Neoadjuvant chemotherapy	Neoadjuvant chemotherapy	Patients who had chemotherapy before surgery.
Surgery alone	Oesophagectomy	Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years	The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	5 years	DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause
R0 resection rate	Baseline	R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).
Pathologic complete response (pCR)	Baseline	pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.
30-day postoperative or in-hospital mortality	30 days

Trial Locations

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