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This is a multicenter, retrospective observational study using existing medical records of patients with esophageal squamous cell carcinoma who received at least two cycles of neoadjuvant immunochemotherapy followed by curative surgery with complete tumor removal and negative surgical margins between January 2021 and December 2024.
The main aim of this study is to evaluate whether postoperative radiotherapy is associated with better control of cancer recurrence in the surgical area and regional lymph nodes, and whether this association differs according to the extent and number of lymph nodes removed during surgery. Patients will not be assigned to any treatment as part of this study. Outcomes will be compared according to postoperative radiotherapy status and lymph node dissection characteristics.
The primary outcome is locoregional recurrence-free survival. Secondary outcomes include disease-free survival, overall survival, and distant metastasis-free survival. Clinical, surgical, pathological, treatment, and follow-up information will be collected from electronic medical records at six esophageal cancer centers. Approximately 300 patients are expected to be included.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative Radiotherapy | Radiation | Receipt or nonreceipt of postoperative radiotherapy after R0 esophagectomy was determined during routine clinical care and was not assigned by the study protocol. Information on radiotherapy dose, target volume, treatment schedule, and completion status will be extracted from existing medical records. | ||
| Lymph Node Dissection | Procedure | Lymph node dissection performed during curative esophagectomy will be evaluated according to the documented anatomical extent of dissection and the number of lymph nodes removed. The surgical procedure was determined during routine clinical care and was not assigned by the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional Recurrence-Free Survival (LRFS) | From the date of surgery to locoregional recurrence, death, or the last available follow-up, assessed up to 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) | Disease-free survival is defined as the time from the date of surgery to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last available follow-up. | From the date of surgery to disease recurrence, death, or the last available follow-up, assessed up to 5 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be selected from the electronic medical record and hospital information system databases of six esophageal cancer centers. Consecutive patients treated between January 2021 and December 2024 will be screened. Eligible patients will have histologically confirmed esophageal squamous cell carcinoma and will have received neoadjuvant immunochemotherapy followed by curative esophagectomy with R0 resection. Existing demographic, clinical, surgical, pathological, postoperative treatment, and follow-up data will be retrospectively extracted. No treatment or exposure will be assigned by the investigators. All eligible patients will be included in one retrospective cohort, with postoperative radiotherapy and lymph node dissection characteristics evaluated as observed clinical exposures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital, Wuhan, Hubei 430030 | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Overall Survival (OS) | Overall survival is defined as the time from the date of surgery to death from any cause. Participants who are alive will be censored at the date of the last confirmed follow-up. | From the date of surgery to death or the last confirmed follow-up, assessed up to 5 years after surgery |
| Distant Metastasis-Free Survival (DMFS) | Distant metastasis-free survival is defined as the time from the date of surgery to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Distant metastasis refers to disease recurrence outside the locoregional area. Participants without an event will be censored at the date of the last available follow-up. | From the date of surgery to distant metastasis, death, or the last available follow-up, assessed up to 5 years after surgery |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |