Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma

Shanghai Zhongshan Hospital303 enrolled

Overview

The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use

background：Neoadjuvant chemoradiotherapy has gradually become a first-line treatment for esophageal squamous cell carcinoma patients. After the completion of neoadjuvant chemoradiotherapy, patients usually undergo minimally invasive surgery to ensure complete removal of the tumor and lymphatic tissue. However, the optimal interval between neoadjuvant chemoradiotherapy and minimally invasive surgery is still an unknown factor, and whether it affects postoperative disease-free survival (DFS) and overall survival (OS) of patients remains unknown. Therefore, the main purpose of this study is to explore the specific impact of the interval between neoadjuvant chemoradiotherapy and minimally invasive surgery on patients, and to find the optimal interval time. methods：Patients who underwent neoadjuvant chemoradiotherapy and minimally invasive surgery from two institutions between October 2010 and September 2019 were included in this study. The time interval is defined as the days between the last time a patient receives neoadjuvant chemoradiotherapy and the execution of surgery. Based on past research, the interval between the two groups was determined to be 50 days. The main research result is the OS and DFS of different interval groups in the overall population and non-PCR population. A multivariate Cox regression model was established to determine the main factors affecting Patient's OS and DFS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

303

Conditions

Time

Interventions

Neoadjuvant chemradiotherapyRADIATION

Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage

Minimally invasive esophagectomyPROCEDURE

The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * (I) thoracic ESCC * (II) no history of concomitant or prior malignancy * (III) Completed one cycle of nCRT * (IV) Received endoscopic radical surgery for esophageal cancer Exclusion Criteria: * (I)other histological subtypes * (II)Received ESD treatment * (III) Radiation dose greater than 50Gy * (IV) Metastatic esophageal squamous cell carcinoma

Locations (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The overall survival of the overall population

Does the overall population survive

Time frame: 5 years

The Disease-Free survival of the overall population

Is there any tumor metastasis or recurrence in the overall population

Time frame: 5 years

The overall survival of the non-PCR population

Does the non-PCR population survive

Time frame: 5 years

The Disease-Free survival of the non-PCR population

Is there any tumor metastasis or recurrence in the non-PCR population

Time frame: 5 years

The overall survival of the PCR population

Does the PCR population survive

Time frame: 5 years

The Disease-Free survival of the PCR population

Is there any tumor metastasis or recurrence in the PCR population

Time frame: 5 years

Data from ClinicalTrials.gov

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