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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027543
• Other study ID #: SYSEC-KY-KS-2019-068
• Status: Completed
• Start date: November 14, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Chemotherapy Effect
• Effect of Drugs
• Esophageal Neoplasms
• Oesophageal Carcinoma
• Radiotherapy Side Effect
• Safety Issues

Intervention

Combination Product:
• Neoadjuvant chemoradiotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

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.

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

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong
United States	Massachusetts General Hospital of Harvard Medical School	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangdong Provincial People's Hospital, Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	R0 resection rate	R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).	Baseline
Secondary	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
Secondary	30-day postoperative or in-hospital mortality		30 days