[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659011":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":38,"overallOfficials":25,"centralContacts":25,"locations":48,"responsibleParty":72,"collaborators":25,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":25,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":25,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"2-Year Locoregional Recurrence-Free Survival","Locoregional recurrence-free survival (LRFS) is defined as the time from the start of radiotherapy to locoregional tumor recurrence, death from any cause, loss to follow-up, or the last follow-up, according to the study protocol. The 2-year LRFS rate will be compared among patients receiving different radiotherapy target volume delineation strategies.","Up to 2 years from the start of radiotherapy",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"2-Year Overall Survival","Overall survival (OS) is defined as the time from the start of radiotherapy to death from any cause, loss to follow-up, or the last follow-up. The 2-year overall survival rate will be evaluated among participants receiving different radiotherapy target volume strategies.","Up to 2 years from radiotherapy",{"measure":19,"description":20,"timeFrame":17},"Marginal and Regional Recurrence Rate","The proportion of participants who develop marginal recurrence or regional lymph node recurrence during follow-up. Recurrence will be determined by pathological or cytological confirmation when available, or by serial imaging showing a new or progressively enlarging lesion consistent with recurrence.",{"measure":22,"description":23,"timeFrame":24},"Incidence of Grade 3 or Higher Treatment-Related Toxicity","The incidence of grade 3 or higher treatment-related adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Toxicities of interest include radiotherapy-related and systemic treatment-related adverse events.","From treatment initiation through 2-year follow-up",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","PROSPECTIVE","This is a prospective, non-interventional observational cohort study of patients with locally advanced esophageal squamous cell carcinoma treated with radiotherapy in combination with immunotherapy in routine clinical practice. Treatment decisions, including radiotherapy target volume delineation and systemic therapy, will be made by the treating physicians according to the patient's clinical condition and routine clinical practice and will not be assigned by the study protocol.\n\nEligible participants will be prospectively followed, and clinical, imaging, pathological, radiotherapy planning, systemic treatment, laboratory, toxicity, and follow-up data will be collected. Participants will be classified according to the radiotherapy strategy actually received, particularly the longitudinal gross tumor volume-to-clinical target volume (GTV-CTV) margin and the extent of regional lymph node irradiation, including involved-field irradiation and approaches incorporating partial elective nodal irradiation.\n\nThe primary objective is to compare 2-year locoregional recurrence-free survival among patients receiving different target volume delineation strategies. Additional outcomes include marginal and regional recurrence patterns, overall survival, treatment-related toxicity, lymphocyte reduction, immunotherapy completion, and other treatment outcomes.\n\nThe study will also evaluate whether clinical and biological factors, including tumor location and length, T and N stage, lymph node burden, PET\u002FCT metabolic parameters, PD-L1 combined positive score, circulating tumor DNA status, and radiotherapy dosimetric parameters, are associated with the effectiveness and safety of different target volume strategies. Target trial emulation, propensity score methods, and multivariable models will be used where appropriate to reduce confounding and to explore factors associated with recurrence and toxicity.","Patients with locally advanced esophageal squamous cell carcinoma who are treated at the National Cancer Center\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College and are considered suitable for definitive or preoperative radiotherapy combined with immunotherapy will be prospectively and consecutively enrolled. Treatment decisions will be made according to routine clinical practice. Participants will be followed to evaluate the association between actual radiotherapy target volume delineation patterns and locoregional control, recurrence, survival, toxicity, lymphocyte reduction, and immunotherapy completion.",[32],{"label":33,"type":25,"description":34,"interventionNames":35},"Locally Advanced ESCC Cohort","Patients with locally advanced esophageal squamous cell carcinoma who receive radiotherapy combined with immunotherapy in routine clinical practice will be prospectively enrolled. Treatment and radiotherapy target volume delineation will not be assigned by the study protocol. Patients will be characterized according to the radiotherapy strategy actually received, including the longitudinal GTV-CTV margin and the extent of regional lymph node irradiation. Clinical, imaging, pathological, dosimetric, treatment, toxicity, and follow-up data will be prospectively collected to evaluate locoregional control, recurrence patterns, survival, lymphocyte reduction, and immunotherapy completion.",[36,37],"Radiation: GTV-CTV Longitudinal Margin","Radiation: Regional Lymph Node Irradiation Strategy",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":25},"RADIATION","GTV-CTV Longitudinal Margin","The longitudinal margin from the gross tumor volume (GTV) to the clinical target volume (CTV) actually used in routine clinical practice will be recorded and analyzed. The study protocol does not assign a specific margin.",[33],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":25},"Regional Lymph Node Irradiation Strategy","The extent of regional lymph node irradiation actually used in routine clinical practice, including involved-field irradiation and approaches incorporating partial elective nodal irradiation, will be recorded and analyzed. The study protocol does not assign a specific nodal irradiation strategy.",[33],[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"National Cancer Center\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},[64,69],{"name":65,"role":66,"phone":67,"phoneExt":25,"email":68},"Xin Wang, PhD","CONTACT","+86-10-87787635","beryl_wx2000@163.com",{"name":70,"role":66,"phone":25,"phoneExt":25,"email":71},"Chao Xi Cao","caoxichao2024@163.com",{"type":73,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100659011","radiotherapy-target-volume-delineation-in-locally-advanced-esophageal-cancer-in-the-immunotherapy-era-100659011",false,"NCT07858630","Radiotherapy Target Volume Delineation in Locally Advanced Esophageal Cancer in the Immunotherapy Era","A Prospective Cohort Study of Radiotherapy Target Volume Delineation Patterns in Locally Advanced Esophageal Cancer in the Immunotherapy Era","Inclusion Criteria:\n\n1. Age 18 to 80 years, regardless of sex.\n2. Histologically confirmed esophageal squamous cell carcinoma.\n3. 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.\n4. Planned to receive one of the following modern precision radiotherapy techniques: IMRT, VMAT, TOMO, proton therapy, or heavy-ion radiotherapy.\n5. Contrast-enhanced CT completed before radiotherapy; endoscopy, EUS, PET\u002FCT, or MRI is recommended when clinically appropriate to assist target volume delineation.\n6. ECOG performance status of 0-2.\n7. Expected survival of at least 6 months.\n8. Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis or malignant pleural or peritoneal effusion.\n2. Previous thoracic radiotherapy that may affect the current target volume design or dose constraints.\n3. Pre-existing esophagotracheal fistula, esophagoaortic fistula, or a high risk of perforation considered unsuitable for radiotherapy.\n4. Active interstitial lung disease, severe infection, or uncontrolled autoimmune disease considered unsuitable for immunotherapy.\n5. Severe missing data that prevent determination of the actual CTV margin, lymph node irradiation extent, or major study outcomes.\n6. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","ALL","18 Years","80 Years",{"count":85,"type":86},500,"ESTIMATED","OBSERVATIONAL","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.\n\nIn 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.\n\nThe 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 recurrence-free survival and to identify radiotherapy approaches that may achieve effective tumor control while reducing unnecessary radiation exposure and treatment-related toxicity.",[90],"Esophageal Squamous Cell Carcinoma",[92,93,94,95,96,97,98],"Locally Advanced Esophageal Cancer","Radiotherapy","Immunotherapy","Clinical Target Volume","Target Volume Delineation","GTV-CTV Margin","Regional Lymph Node Irradiation","2026-09-29",{"date":101,"type":102},"2026-10-05","ACTUAL",{"date":104,"type":102},"2026-08-23",{"date":106,"type":86},"2036-08-31",{"name":5,"class":6},1]