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

Sun Yat-sen University

Status: Completed

Conditions: Radiotherapy Side Effect; Chemotherapy Effect; Effect of Drugs; Oesophageal Carcinoma; Safety Issues

Treatments: Procedure: Oesophagectomy; Combination Product: Neoadjuvant chemoradiotherapy; Drug: Neoadjuvant chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT04027543

SYSEC-KY-KS-2019-068

Details and patient eligibility

About

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

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.

Enrollment: 423 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

423 participants in 3 patient groups

Neoadjuvant chemoradiotherapy

Description:

Patients who had chemoradiotherapy before surgery.

Treatment:

Combination Product: Neoadjuvant chemoradiotherapy

Neoadjuvant chemotherapy

Description:

Patients who had chemotherapy before surgery.

Treatment:

Drug: Neoadjuvant chemotherapy

Surgery alone

Description:

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.

Treatment:

Procedure: Oesophagectomy