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)

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy Effect; Safety Issues; Radiotherapy Side Effect; Effect of Drugs; Oesophageal Carcinoma
• Intervention / Treatment: Combination product: Neoadjuvant chemoradiotherapy; Drug: Neoadjuvant chemotherapy; Procedure: Oesophagectomy

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 Type: Observational
• Enrollment (Actual): 423

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Provincial People's Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 01748
      • Massachusetts General Hospital of Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction that was 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 were eligible.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant chemoradiotherapy; Patients who had chemoradiotherapy before surgery.	Combination product: Neoadjuvant chemoradiotherapy; In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
Neoadjuvant chemotherapy; Patients who had chemotherapy before surgery.	Drug: Neoadjuvant chemotherapy; In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
Surgery alone; 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.	Procedure: Oesophagectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	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.	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Massachusetts General Hospital; Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Haiyu Zhou, PhD, Guangdong Provincial People's Hospital; Principal Investigator: Michael Lanuti, PhD, Massachusetts General Hospital of Harvard Medical School

Publications and helpful links

General Publications

• Zhou HY, Zheng SP, Li AL, Gao QL, Ou QY, Chen YJ, Wu ST, Lin DG, Liu SB, Huang LY, Li FS, Zhu HY, Qiao GB, Lanuti M, Yao HR, Yu YF. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study). EClinicalMedicine. 2020 Jun 27;24:100422. doi: 10.1016/j.eclinm.2020.100422. eCollection 2020 Jul.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2018
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Neoadjuvant chemotherapy; Effective; Neoadjuvant chemoradiotherapy; Resectable oesophageal carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: SYSEC-KY-KS-2019-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No