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

April 10, 2024 updated by: Shanghai Zhongshan Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short interval group
The patient underwent minimally invasive esophagectomy within 50 days after receiving neoadjuvant therapy
Radiation: Neoadjuvant chemradiotherapy
Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage
Procedure: Minimally invasive esophagectomy
The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes
Experimental: Long interval group
The patient underwent minimally invasive esophagectomy 50 days after receiving neoadjuvant therapy
Radiation: Neoadjuvant chemradiotherapy
Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage
Procedure: Minimally invasive esophagectomy
The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall survival of the overall population
Time Frame: 5 years
Does the overall population survive
5 years
The Disease-Free survival of the overall population
Time Frame: 5 years
Is there any tumor metastasis or recurrence in the overall population
5 years
The overall survival of the non-PCR population
Time Frame: 5 years
Does the non-PCR population survive
5 years
The Disease-Free survival of the non-PCR population
Time Frame: 5 years
Is there any tumor metastasis or recurrence in the non-PCR population
5 years
The overall survival of the PCR population
Time Frame: 5 years
Does the PCR population survive
5 years
The Disease-Free survival of the PCR population
Time Frame: 5 years
Is there any tumor metastasis or recurrence in the PCR population
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2010

Primary Completion (Actual)

October 15, 2016

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • time-exploring

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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