Clinical trial NCT06364566: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma
Official title: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 303
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The overall survival of the overall population
timeFrame: 5 years
measure: The Disease-Free survival of the overall population
timeFrame: 5 years
measure: The overall survival of the non-PCR population
timeFrame: 5 years
measure: The Disease-Free survival of the non-PCR population
timeFrame: 5 years
measure: The overall survival of the PCR population
timeFrame: 5 years
measure: The Disease-Free survival of the PCR population
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
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