An observational study in Esophageal Squamous Cell Carcinoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational
This retrospective real-world cohort study will evaluate the efficacy and safety of different radiotherapy target volume extents in patients with locally advanced esophageal squamous cell carcinoma.
Patients who previously received definitive or preoperative radiotherapy, with systemic treatment consisting of concurrent chemoradiotherapy with or without immunotherapy, will be identified from existing medical records. The study will not assign or modify any treatment.
Patients will be classified according to the radiotherapy target volume actually used in clinical practice, including the longitudinal gross tumor volume-to-clinical target volume (GTV-CTV) margin and the extent of regional lymph node irradiation. The study will compare locoregional recurrence-free survival, recurrence patterns, overall survival, progression-free or disease-free survival, treatment completion, treatment-related toxicity, lymphocyte reduction, and postoperative outcomes among different target volume strategies.
The aim is to provide real-world evidence to support individualized radiotherapy target volume selection in locally advanced esophageal squamous cell carcinoma.
This is a single-center, non-interventional, retrospective real-world cohort study of patients with locally advanced esophageal squamous cell carcinoma. Eligible patients treated between January 1, 2018 and July 15, 2026 will be identified from existing clinical records. Data will be obtained from electronic medical records, hospital information systems, laboratory systems, imaging systems, pathology databases, radiotherapy treatment planning systems, DICOM-RT files, medication records, surgical records, and routine follow-up data.
The study will include patients who previously received definitive or preoperative radiotherapy using modern radiotherapy techniques. Systemic treatment may include concurrent chemoradiotherapy with or without immunotherapy. All treatment decisions were made by the treating clinical team according to the patient's condition and routine clinical practice. The study does not assign, modify, or influence treatment.
Radiotherapy plans will be retrospectively reviewed. Patients will be classified according to two main exposure dimensions: the longitudinal GTV-CTV margin and the extent of regional lymph node irradiation. For the primary analysis of the longitudinal margin, patients with margins of 2 cm or less on both sides will be classified as the reduced-margin group, whereas patients with a margin greater than 2 cm on either side will be classified as the conventional-margin group. Regional lymph node irradiation will be categorized as involved-field irradiation or partial/elective nodal irradiation according to the original treatment plan.
The primary efficacy outcome is 2-year locoregional recurrence-free survival. Primary safety outcomes include grade 3 or higher treatment-related adverse events occurring from treatment initiation through 90 days after completion of radiotherapy and grade 4 lymphocyte reduction during treatment. Secondary outcomes include overall survival, progression-free survival, disease-free survival in surgical patients, distant metastasis-free survival, recurrence patterns, treatment completion, postoperative outcomes, radiotherapy-related toxicities, and changes in peripheral blood lymphocyte counts.
Propensity score methods, multivariable regression, subgroup analyses, and sensitivity analyses will be used to reduce confounding and evaluate the association between radiotherapy target volume extent and clinical outcomes.
657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.
This study's planned enrollment of 500 is above the median of 285 across 94 observational studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.
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Patients with locally advanced esophageal squamous cell carcinoma who received definitive or preoperative radiotherapy at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, between January 1, 2018 and July 15, 2026 will be retrospectively identified from existing clinical records. Eligible patients will be consecutively screened according to predefined inclusion and exclusion criteria. Data will be obtained from electronic medical records, imaging systems, pathology databases, radiotherapy planning systems, DICOM-RT files, treatment records, surgical records, and routine follow-up data. Treatment decisions were made in routine clinical practice and were not assigned or modified by this study.
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Exclusion Criteria:
Patients whose longitudinal GTV-to-CTV margins are ≤2 cm on both the superior and inferior sides in the original radiotherapy plan.
Patients whose longitudinal GTV-to-CTV margin is \>2 cm on either the superior or inferior side in the original radiotherapy plan.
2-Year Locoregional Recurrence-Free Survival
Locoregional recurrence-free survival (LRFS) is defined as the time from the start of radiotherapy to recurrence of the primary tumor or regional lymph nodes, death from any cause, or the last follow-up. Locoregional recurrence will be determined based on pathological findings, serial imaging progression, and clinical information.
Time frame: Up to 2 years from the start of radiotherapy
2-Year Overall Survival
Overall survival (OS) is defined as the time from initiation of radiotherapy to death from any cause. Patients alive at their last available follow-up will be censored at that date. The 2-year OS probability will be estimated.
Time frame: From initiation of radiotherapy to death from any cause or last follow-up, up to 24 months.
Plan to share: No
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Started Jan 2018 (actual). Primary completion is estimated for Jun 2030, 149 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Esophageal Squamous Cell Carcinoma →
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →