CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 264 enrolled
Drug / intervention
Neoadjuvant Chemoradiotherapy +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03001596
NCT03001596N/ACompleted

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 Hospital·interventional·Posted Dec 23, 2016·Updated Sep 10, 2020

In Brief

A clinical study evaluating Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy, and 1 other intervention for Esophageal Squamous Cell Carcinoma Stage cT3-4aN0-1M0. Completed, enrolled 264 participants across 1 site.

Detailed 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).

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 23, 2016
Enrollment StartJan 1, 2017
Primary CompletionFeb 1, 2019
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.5 years ago

Interventions

Neoadjuvant Chemoradiotherapyprocedure

Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.

Neoadjuvant Chemotherapyprocedure

Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.

Minimally Invasive Esophagectomyprocedure

After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy