[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621258":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":15,"studyPopulation":15,"armGroups":46,"interventions":51,"overallOfficials":15,"centralContacts":57,"locations":15,"responsibleParty":63,"collaborators":15,"id":67,"slug":15,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":15,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":15,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":15,"overallStatus":84,"whyStopped":15,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":15},{"fullName":5,"class":6},"Jiangxi Provincial Cancer Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"6m PFS","6-month progression-free survival rate","up to 6 month",{"measure":14,"description":15,"timeFrame":16},"incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher",null,"Up to 24 months",[18,21,24,27,31,34,37],{"measure":19,"description":20,"timeFrame":16},"OS","overall survival",{"measure":22,"description":23,"timeFrame":16},"Location of first recurrence relative to radiation field (in-field, marginal, or distant)","The spatial relationship between the first documented site of disease recurrence\u002Fprogression and the original radiation treatment plan will be determined by a core imaging laboratory. Recurrent lesions will be co-registered with the original planning CT\u002FMRI and radiation dose distribution.\n\nClassification is based on the volume of the recurrent lesion covered by the 95% isodose line of the original prescription dose:\n\nIn-field recurrence: \\>80% of the recurrent lesion's volume is within the 95% isodose line.\n\nMarginal recurrence: 20% to 80% of the recurrent lesion's volume is within the 95% isodose line.\n\nDistant recurrence: \\\u003C20% of the recurrent lesion's volume is within the 95% isodose line.\n\nThis classification criteria is adapted from the dosimetric analysis methods commonly used in radiotherapy studies (e.g., Patterns offailure for glioblastoma multiforme following limited-margin radiation and concurrent temozolomide. Radiation oncology 2014, 9:130.)",{"measure":25,"description":26,"timeFrame":16},"Cognitive function assessed by Mini-Mental State Examination (MMSE) score","Cognitive function assessed by the Mini-Mental State Examination (MMSE). Scores range from 0 to 30, with higher scores indicating better cognitive function.",{"measure":28,"description":29,"timeFrame":30},"Cognitive function assessed by Montreal Cognitive Assessment (MoCA) score","Cognitive function assessed by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function.","Up to 24 months.",{"measure":32,"description":33,"timeFrame":16},"Health-Related Quality of Life as assessed by the EORTC QLQ-C30 Global Health Status \u002F QoL scale","Score on the Global Health Status \u002F Quality of Life scale (Items 29 \\& 30) of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scale range: 0-100. A higher score indicates a better overall quality of life.",{"measure":35,"description":36,"timeFrame":16},"Disease-Specific Quality of Life as assessed by the EORTC QLQ-BN20 summary score","Summary score of the European Organization for Research and Treatment of Cancer Brain Cancer Module (EORTC QLQ-BN20). This scale assesses symptoms and issues specific to brain tumor patients (e.g., future uncertainty, visual disorder, motor dysfunction). Scale range and interpretation should be specified",{"measure":38,"description":39,"timeFrame":16},"Quality of Life as assessed by the FACT-Br Total Score","Total score of the Functional Assessment of Cancer Therapy - Brain (FACT-Br). This questionnaire assesses physical, social, emotional, functional well-being, and additional concerns specific to brain tumor patients. Scale range: 0-200. A higher score indicates better quality of life.",{"allocation":41,"interventionModel":42,"interventionModelDescription":15,"primaryPurpose":43,"observationalModel":15,"timePerspective":15,"maskingInfo":44},"NA","SINGLE_GROUP","PREVENTION",{"masking":45,"maskingDescription":15,"whoMasked":15},"NONE",[47],{"label":48,"type":6,"description":15,"interventionNames":49},"limited-field radiotherapy Group",[50],"Radiation: limited-field radiotherapy",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":15},"RADIATION","limited-field radiotherapy","limited-field radiotherapy + Concurrent and adjuvant TMZ chemotherapy",[48],[58],{"name":59,"role":60,"phone":61,"phoneExt":15,"email":62},"Ziwei Tu","CONTACT","13755793552","tuziwei198803@163.com",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"PRINCIPAL_INVESTIGATOR","Zhiping Chen","Director of the Head and Neck Radiation Therapy Department，Jiangxi cancer Hospital","100621258",false,"NCT07368283","Limited Target Volume Radiotherapy After Glioblastoma Surgery","A Single-arm Phase II Non-inferiority Clinical Study of Limited Target Volume Radiotherapy After Glioblastoma Surgery","Inclusion Criteria:\n\n* Aged between 18 and 70 years.\n* Diagnosed with glioblastoma by surgical pathology, with the extent of resection achieving maximal safe resection.\n* Within 2 to 6 weeks after surgery\n* In good physical condition with a Karnofsky Performance Status (KPS) score ≥ 60.\n* Hematological, hepatic, and renal functions are essentially normal.\n* Signed informed consent, willing to undergo treatment and follow-up as stipulated in the study protocol.\n\nExclusion Criteria:\n\n* Prior history of cranial radiotherapy or other malignant tumors.\n* Severe dysfunction of vital organs (e.g., heart, liver, kidneys) that precludes tolerance to radiotherapy.\n* Active infection, immune system disorders, or other serious chronic diseases.\n* Pregnancy or lactation.\n* Psychiatric disorders or severe cognitive impairment that compromises the ability to cooperate with treatment and follow-up.","ALL","18 Years","70 Years",{"count":77,"type":78},79,"ESTIMATED","INTERVENTIONAL",[41],"Research on radiotherapy target volumes for glioblastoma is increasingly focused on exploring more limited yet effective irradiation fields, aiming to achieve local control while minimizing acute and long-term neurotoxicity. Previous retrospective analysis by investigators revealed that local recurrences of glioblastoma are predominantly confined to a narrow margin around the original lesion: 98.3% of recurrences occurred within 0.5 cm of the original T2-FLAIR abnormality, 94.8% within 1 cm of the original T1-enhanced region. These findings have been cited in the ESTRO-EANO treatment guidelines. Building on this evidence, investigators plan to conduct a single-arm, phase II clinical trial to systematically evaluate the efficacy and safety of a 1 cm radiotherapy target volume in post-operative glioblastoma patients.Eligible patients with glioblastoma who have undergone surgical resection will be selected to receive limited-field radiotherapy. The target volume will be defined based on the postoperative MRI enhancing lesion: a 1 cm margin will be added to form the clinical target volume (CTV), followed by a further 0.3 cm margin to create the planning target volume (PTV). A total dose of 60 Gy will be delivered in 30 fractions (2 Gy per fraction, 5 fractions per week). Concurrent and adjuvant chemotherapy will be administered per standard guidelines. The primary efficacy endpoints are the 6-month progression-free survival rate and the incidence of symptomatic radiation-induced brain necrosis of grade 3 or higher. Secondary endpoints include overall survival, patterns of recurrence, neurocognitive function, and quality of life.",[83],"Glioblastoma (GBM)","NOT_YET_RECRUITING","2026-01-28",{"date":87,"type":88},"2026-01-30","ACTUAL",{"date":90,"type":78},"2026-01",{"date":92,"type":78},"2030-12",{"name":5,"class":6}]