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Radiotherapy Target Volume Delineation in Locally Advanced Esophageal Cancer in the Immunotherapy Era

Recruitingn/aAges 18 Years - 80 YearsAllCancer Institute and Hospital, Chinese Academy ofโ€ฆ
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In plain words

What the trial is, and whether it could suit you

This prospective observational cohort study will evaluate different radiotherapy target volume delineation patterns in patients with locally advanced esophageal squamous cell carcinoma receiving radiotherapy combined with immunotherapy. In routine clinical practice, physicians may use different margins around the primary tumor and different approaches to regional lymph node irradiation. The study will not assign participants to a specific radiotherapy strategy. Instead, participants will receive treatment according to routine clinical practice, and the actual radiotherapy plans will be recorded and analyzed. The study will compare locoregional tumor control, recurrence patterns, survival, treatment-related toxicity, lymphocyte reduction, and completion of immunotherapy among patients receiving different target volume strategies. The main objective is to evaluate 2-year locoregional rec

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 to 80 years, regardless of sex. 2. Histologically confirmed esophageal squamous cell carcinoma. 3. Clinical stage cT2-4aN0-3M0, or considered by a multidisciplinary team to be suitable for definitive immunotherapy combined with radiotherapy or preoperative immunotherapy combined with radiotherapy. 4. Planned to receive one of the following modern precision radiotherapy techniques: IMRT, VMAT, TOMO, proton therapy, or heavy-ion radiotherapy. 5. Contrast-enhanced CT completed before radiotherapy; endoscopy, EUS, PET/CT, or MRI is recommended when clinically appropriate to assist target volume delineation. 6. ECOG performance status of 0-2. 7. Expected survival of at least 6 months. 8. Able to understand the study and provide written informed consent. Exclusion Criteria: 1. Presence of distant metastasis or malignant pleural or peritoneal effusion. 2. Previous thoracic radiotherapy that may affect the current target volume design or dose constraints. 3. Pre-existing esophagotracheal fistula, esophagoaortic fistula, or a high risk of perforation considered unsuitable for radiotherapy. 4. Active interstitial lung disease, severe infection, or uncontrolled autoimmune disease considered unsuitable for immunotherapy. 5. Severe missing data that prevent determination of the actual CTV margin, lymph node irradiation extent, or major study outcomes. 6. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
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What it tests

  • GTV-CTV Longitudinal Margin
  • Regional Lymph Node Irradiation Strategy
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Where

1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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