Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 8:25 AM
Study NCT ID:
NCT06364566
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: