[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593613":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":48,"responsibleParty":77,"collaborators":28,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":28,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":28,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Creating CTV for primary tumor.",[13,14,15,16],"Radiation: Radiation Therapy","Drug: Etoposide + carboplatin; Etoposide + cisplatin","Radiation: Creating CTV for primary tumor","Radiation: prophylactic cranial irradiation (PCI)",{"label":18,"type":19,"description":20,"interventionNames":21},"Experimental group","EXPERIMENTAL","Omitting CTV for primary tumor.",[13,14,16],[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Radiation Therapy","Twice-daily (45 Gy\u002F30 fractions) or once-daily (45 Gy\u002F15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy",[9,18],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Etoposide + carboplatin; Etoposide + cisplatin","Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg\u002Fm2) on days 1-3, or cisplatin IV (25mg\u002Fm2) on days 1-3 combined with etoposide IV (100mg\u002Fm2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles.",[9,18],{"type":24,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Creating CTV for primary tumor","A margin of 0.8 cm beyond the gross target volume of primary tumor.",[9],{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"prophylactic cranial irradiation (PCI)","Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy\u002F10 fractions or 26 Gy\u002F13 fractions, delivered once daily (5 days per week).",[9,18],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Ming Chen","CONTACT","86+02087343504","chenming@sysucc.org.cn",[49,65],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":58,"coordinates":59},"Point",[60,61],113.25,23.11667,{"lat":61,"lon":60},[64],{"name":44,"role":45,"phone":28,"phoneExt":28,"email":28},{"facility":66,"status":51,"city":67,"state":68,"zip":28,"country":55,"countryCode":56,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Zhejiang Provincial Cancer Hospital","Hangzhou","Zhejiang",{"type":58,"coordinates":70},[71,72],120.16142,30.29365,{"lat":72,"lon":71},[75],{"name":76,"role":45,"phone":28,"phoneExt":28,"email":28},"Xiao Hu",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Shuohan Zheng","Dr.","100593613","phase-3-omitting-ctv-for-primary-tumor-in-ls-sclc-100593613",false,"NCT07008716","Omitting CTV for Primary Tumor in LS-SCLC","Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;\n2. Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;\n3. Have measurable lesions per RECIST 1.1 criteria;\n4. Have no disease progression after 2-4 cycles of etoposide\u002Fcarboplatin or etoposide\u002Fcisplatin;\n5. Lung function test: FEV1 ≥ 1 L (Optional);\n6. Complete blood count: neutrophil count ≥ 1.5 x 10\\^9\u002FL, hemoglobin ≥ 100 g\u002FL, platelet count ≥ 100 x 10\\^9\u002FL;\n7. Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);\n8. Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;\n9. Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.\n\nExclusion Criteria:\n\n1. Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;\n2. Uncontrolled heart disease or myocardial infarction within the past 6 months;\n3. Patients with a history of mental illness;\n4. Pregnant and lactating patients;\n5. Poorly controlled diabetes and hypertension;\n6. Interstitial pneumonia or active pulmonary fibrosis;\n7. Active infection;\n8. Other conditions unsuitable for enrollment (per investigator judgment).","ALL","18 Years","75 Years",{"count":92,"type":93},852,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.",[99,100,101,102],"SCLC, Limited Stage","Radiation Exposure","Radiotherapy Side Effect","Progression","2025-05-29",{"date":105,"type":106},"2025-06-06","ACTUAL",{"date":108,"type":93},"2025-06-03",{"date":110,"type":93},"2032-12-31",{"name":5,"class":6},2]