Neoadjuvant Chemoradiotherapy VS. Neoadjuvant Chemotherapy Followed by Minimally Invasive Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma（cT3-4aN0-1M0):A Multi-center Prospective Randomized Clinical Trial

Shanghai Zhongshan Hospital1 site in 1 country264 target enrollmentJanuary 2017

ConditionsEsophageal Squamous Cell Carcinoma Stage cT3-4aN0-1M0

Overview

Phase: N/A
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma Stage cT3-4aN0-1M0
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 264
Locations: 1
Primary Endpoint: Overall survival(OS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).

Detailed Description

It is a prospective randomized phase III clinical trial sponsored by Shanghai Zhongshan Hospital with other eight hospitals in China participating in. 264 patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (NCRT group) and the neoadjuvant chemotherapy group (NCT group) according to the proportion of 1:1.The safety,efficacy of protocols and prognosis of patients are compared between the two regimens.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

August 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically-confirmed squamous cell carcinoma of the esophagus;
•Tumors of the esophagus are located in the thoracic cavity;
•Pre-treatment stage as cT3-4aN0-1M0 (AJCC/UICC 7th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization).
•Age is between 18 years and 75 years,
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
•Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \> 50 %.
•Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests.
•Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L);
•Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN);
•Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L)；

Exclusion Criteria

•Patients with non-squamous cell carcinoma histology;
•Patients with advanced inoperable or metastatic esophageal cancer;
•Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition);
•Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 7th Edition);
•Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator.
•Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder;
•Pregnant or lactating women and fertile women who will not be using contraception during the trial;
•Allergy to any drugs;
•Participation in another intervention clinical trial with interference to the chemotherapeutic or chemoradiotherapeutic intervention during this study or during the last 30 days prior to informed consent;
•Expected lack of compliance with the protocol.

Outcomes

Primary Outcomes

Overall survival(OS)

Time Frame: Up to the date of death of any causes since the date of randomization, up to 36 months

Secondary Outcomes

Progression-free survival(PFS)(Up to the date of disease recurrence since the date of randomization, up to 36 months)
Pathological response rate(pCR)(Up to the date of pathological reports obtained since the date of randomization, up to 12 months)
R0 resection rate(Up to the date of pathological reports obtained since the date of randomization, up to 12 months)
Positive lymph nodes' number(Up to the date of pathological reports obtained since the date of randomization, up to 12 months)
Treatment related complications(Up to 1 month after surgery since the data of randomization, up to 13 months)
Quality of life(QOL)(Up to the end of follow-up since the data of surgery, up to 36 months)
Recurrence-free survival (RFS)(Up to the date of disease recurrence since the date of surgery, up to 36 months)