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

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

Detailed Description
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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.

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

Conditions
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Radiotherapy Side Effect, Chemotherapy Effect, Oesophageal Carcinoma, Effect of Drugs, Safety Issues

Intervention / Treatment
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* Combination Product: Neoadjuvant chemoradiotherapy
* Procedure: Oesophagectomy
* Drug: Neoadjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neoadjuvant chemoradiotherapy<br>Patients who had chemoradiotherapy before surgery. | Combination Product: Neoadjuvant chemoradiotherapy<br>* In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.<br>|
| Neoadjuvant chemotherapy<br>Patients who had chemotherapy before surgery. | Drug: Neoadjuvant chemotherapy<br>* In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.<br>|
| Surgery alone<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant chemoradiotherapy, Neoadjuvant chemotherapy, Resectable oesophageal carcinoma, Effective, Safety