Skip to main content
OpenTrials
Completed

NCT Number: NCT06364566

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Time

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neoadjuvant chemradiotherapy

Radiation

Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage

minimally invasive esophagectomy

Procedure

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

Primary outcomes

  1. The overall survival of the overall population

    Time frame: 5 years

    Does the overall population survive

  2. The Disease-Free survival of the overall population

    Time frame: 5 years

    Is there any tumor metastasis or recurrence in the overall population

  3. The overall survival of the non-PCR population

    Time frame: 5 years

    Does the non-PCR population survive

  4. 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. The overall survival of the PCR population

    Time frame: 5 years

    Does the PCR population survive

  6. The Disease-Free survival of the PCR population

    Time frame: 5 years

    Is there any tumor metastasis or recurrence in the PCR population

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2019
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.