Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 303
- Locations
- 1
- Primary Endpoint
- The Disease-Free survival of the overall population
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The Disease-Free survival of the overall population
Time Frame: 5 years
Is there any tumor metastasis or recurrence in the overall population
The overall survival of the overall population
Time Frame: 5 years
Does the overall population survive
The Disease-Free survival of the PCR population
Time Frame: 5 years
Is there any tumor metastasis or recurrence in the PCR population
The overall survival of the non-PCR population
Time Frame: 5 years
Does the non-PCR population survive
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
The overall survival of the PCR population
Time Frame: 5 years
Does the PCR population survive
Secondary Outcomes
No secondary outcomes reported