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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short interval group | Experimental | The patient underwent minimally invasive esophagectomy within 50 days after receiving neoadjuvant therapy |
|
| Long interval group | Experimental | The patient underwent minimally invasive esophagectomy 50 days after receiving neoadjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemradiotherapy | Radiation | Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage |
|
| Measure | Description | Time Frame |
|---|---|---|
| The overall survival of the overall population | Does the overall population survive | 5 years |
| The Disease-Free survival of the overall population | Is there any tumor metastasis or recurrence in the overall population | 5 years |
| The overall survival of the non-PCR population | Does the non-PCR population survive | 5 years |
| The Disease-Free survival of the non-PCR population | Is there any tumor metastasis or recurrence in the non-PCR population | 5 years |
| The overall survival of the PCR population | Does the PCR population survive | 5 years |
| The Disease-Free survival of the PCR population | Is there any tumor metastasis or recurrence in the PCR population | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Result | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 26376349 | Result | Ohashi S, Miyamoto S, Kikuchi O, Goto T, Amanuma Y, Muto M. Recent Advances From Basic and Clinical Studies of Esophageal Squamous Cell Carcinoma. Gastroenterology. 2015 Dec;149(7):1700-15. doi: 10.1053/j.gastro.2015.08.054. Epub 2015 Sep 12. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2021 | Apr 10, 2024 | SAP_000.pdf |
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| Minimally invasive esophagectomy | Procedure | The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes |
|
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