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临床试验 NCT06492486 (GLADIATOR) 针对弥漫性胶质瘤，胶质母细胞瘤，适应性放疗，人工智能目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow (GLADIATOR) II期 60 适应性设计
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临床试验NCT06492486 (GLADIATOR)旨在研究治疗，主要针对弥漫性胶质瘤，胶质母细胞瘤，适应性放疗，人工智能。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年11月30日开始，预计招募60名患者。该研究由Tata Memorial Centre主导，计划于2028年7月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月16日。
简要概括
Gliomas are common primary brain tumors in adults. Gliomas can be classified into different types based on tumor grade, histopathological features, and molecular characteristics. The common types of diffuse gliomas include glioblastoma, astrocytoma, and oligodendroglioma. The standard treatment for diffuse gliomas includes surgery followed by radiation and chemotherapy. As per standard institutional practice, a unifo...显示更多
详细描述
Glioblastoma multiforme (GBM) represents grade 4 diffuse gliomas accounting for the most common primary malignant central nervous system (CNS) tumors in adults . GBM is treated with radiotherapy (RT) and concurrent chemotherapy following maximal safe resection, with a median survival of approximately 15-18 months . GBM harbors significant intratumoral heterogeneity with areas of multiclonal and hypoxic areas renderin...显示更多
官方标题
Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow
疾病
弥漫性胶质瘤胶质母细胞瘤适应性放疗人工智能出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- GLADIATOR
- 4384
NCT编号
实际开始日期
2025-11-30
最近更新发布
2025-09-16
预计完成日期
2028-07-30
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Stratum A (IDH-negative GBM) Adaptive radiotherapy | 适应性放疗 Volumetric and biological adaptive radiotherapy will be delivered based on interval imaging with MRI and PET scan during treatment. |
实验性Stratum B (IDH-mutant astrocytoma or oligodendroglioma) Adaptive radiotherapy | 适应性放疗 Volumetric and biological adaptive radiotherapy will be delivered based on interval imaging with MRI and PET scan during treatment. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Proportion of patients undergoing volumetric and biological adaptation. Cumulative rate of symptomatic radionecrosis (RN) at 2 years. | Proportion of patients where modification of radiation plan was done. | 2 years |
Cumulative rate of symptomatic radionecrosis at 2 years | Patients developing symptomatic radionecerosis will be analyzed using Kaplan-Meier survival method. | 4 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Progression free survival | Progression free survival will be analyzed using Kaplan Meier method. | 4 years |
Overall survival | Overall survival will be analyzed using Kaplan Meier method. | 4 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Histological diagnosis of diffuse glioma. Patients with IDH-negative GBM (stratum A) and IDH-mutant glioma (astrocytoma or oligodendroglioma) need radiotherapy (stratum B).
Age: 18-70 years. Karnofsky Performance Scale (KPS) ≥60
- Multifocal or multicentric disease Not eligible for radical intent radiation. IDH status is unknown or uninterpretable (IHC or gene sequencing). Use of prior radiotherapy to the head-neck region or brain or chemotherapy. Contraindication/unable to undergo MRI or PET scan during radiation.
Tata Memorial Centre研究责任方
Dr Archya Dasgupta, 主要研究者, Assistant Professor, Radiation Oncology, Tata Memorial Centre
研究中心联系人
联系人: Archya Dasgupta, 2224177000, [email protected]
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