Skip to main content
OpenTrials
Completed

NCT Number: NCT04027543

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiotherapy Side Effect Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Effect of Drugs Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Oesophageal Carcinoma Radiation Injuries Safety Issues Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neoadjuvant chemoradiotherapy

Combination Product

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Oesophagectomy

Procedure

Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

Neoadjuvant chemotherapy

Drug

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Primary outcomes

  1. Overall survival (OS)

    Time frame: 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 outcomes

  1. Disease-free survival (DFS)

    Time frame: 5 years

    DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause

  2. R0 resection rate

    Time frame: Baseline

    R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).

  3. Pathologic complete response (pCR)

    Time frame: Baseline

    pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.

  4. 30-day postoperative or in-hospital mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Guangdong Provincial People's Hospital
  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2019
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.