Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma
NCT ID: NCT06364566
Last Updated: 2024-04-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
303 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-10-15
Study Completion Date
2019-10-15
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Time
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Short interval group
The patient underwent minimally invasive esophagectomy within 50 days after receiving neoadjuvant therapy
Group Type
EXPERIMENTAL
Neoadjuvant chemradiotherapy
Intervention Type
RADIATION
Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage
Minimally invasive esophagectomy
Intervention Type
PROCEDURE
The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes
Long interval group
The patient underwent minimally invasive esophagectomy 50 days after receiving neoadjuvant therapy
Group Type
EXPERIMENTAL
Neoadjuvant chemradiotherapy
Intervention Type
RADIATION
Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage
Minimally invasive esophagectomy
Intervention Type
PROCEDURE
The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes
Interventions
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Neoadjuvant chemradiotherapy
Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage
Intervention Type
RADIATION
Minimally invasive esophagectomy
The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* (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
* (II)Received ESD treatment
* (III) Radiation dose greater than 50Gy
* (IV) Metastatic esophageal squamous cell carcinoma
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Site Status
Countries
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China
References
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Reference Type
RESULT
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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time-exploring
Identifier Type: -
Identifier Source: org_study_id
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