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

Fudan University

Status: Completed

Conditions: Time

Treatments: Procedure: Minimally invasive esophagectomy; Radiation: Neoadjuvant chemradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06364566

time-exploring

Details and patient eligibility

About

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

Full 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.

Enrollment: 303 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

Short interval group

Experimental group

Description:

The patient underwent minimally invasive esophagectomy within 50 days after receiving neoadjuvant therapy

Treatment:

Procedure: Minimally invasive esophagectomy

Radiation: Neoadjuvant chemradiotherapy

Long interval group

Experimental group

Description:

The patient underwent minimally invasive esophagectomy 50 days after receiving neoadjuvant therapy

Treatment:

Procedure: Minimally invasive esophagectomy

Radiation: Neoadjuvant chemradiotherapy