[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557749":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":64,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The study group","EXPERIMENTAL","Patients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 45-50Gy\u002F3-4 fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.",[13],"Radiation: Online adaptive SBRT",{"label":15,"type":16,"description":17,"interventionNames":18},"The control group","ACTIVE_COMPARATOR","Patients in the control group will receive conventional standard stereotactic body radiotherapy. The total dose will be 45-50Gy\u002F3-4 fractions, administered once daily. CBCT will be acquired before initiating treatment at each fraction.",[19],"Radiation: Conventional SBRT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Online adaptive SBRT","Online adaptive SBRT (without PTV expansion margin). The total dose will be 45-50Gy\u002F3-4 fractions, administered once daily. FBCT and 4DCT will be acquired.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional SBRT","SBRT with PTV expansion. The total dose will be 45-50Gy\u002F3-4 fractions, administered once daily. CBCT will be acquired.",[15],[32],{"name":33,"affiliation":34,"role":35},"Hui Liu, Professor","Sun yat-sen universtiy cancer center","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Bo Qiu, Professor","CONTACT","+862087343031","qiubo@sysucc.org.cn",{"name":33,"role":39,"phone":40,"phoneExt":26,"email":43},"liuhui@sysucc.org.cn",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Sun yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":54,"coordinates":55},"Point",[56,57],113.25,23.11667,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":62,"phoneExt":26,"email":63},"Hui Liu, MD","+86-020-87343031","liuhuisysucc@126.com",{"type":35,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hui Liu","Professor","100557749","phase-2-elimination-of-ptv-margins-based-on-online-adaptive-stereotactic-radiotherapy-for-early-stage-non-small-cell-lung-cancer-or-pulmonary-oligometastases-100557749",false,"NCT06542159","Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases","Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study","Inclusion Criteria:\n\n* Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT\u002Fchest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm).\n* Age 18 years or older, regardless of gender.\n* ECOG performance status score of 0-2.\n* Serum hemoglobin ≥ 80 g\u002FL, platelets ≥ 100,000\u002FμL, absolute neutrophil count ≥ 1,500\u002FμL.\n* Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml\u002Fmin.\n* Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.\n* FEV1 ≥ 0.5 L.\n* Normal CB6 range.\n* The patient and their family agree and sign the informed consent form.\n\nExclusion Criteria:\n\n* Tumors with bronchial invasion are excluded.\n* Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).\n* Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.\n* Individuals with substance abuse issues, chronic alcoholism, or AIDS.\n* Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.\n* Individuals with a history of severe allergies or specific sensitivities.","ALL","18 Years",{"count":77,"type":78},130,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.",[84,85,86,87,88],"Adaptive Radiotherapy","Stereotactic Body Radiotherapy","Non-small Cell Lung Cancer","Lung Oligometastases","Toxicity",[90,91,86,92,88],"Online adaptive radiotherapy","Stereotactic body radiotherapy","Lung oligometastases","2025-11-13",{"date":95,"type":96},"2025-11-17","ACTUAL",{"date":98,"type":96},"2024-05-22",{"date":100,"type":78},"2028-04-21",{"name":5,"class":6},1]