NCT03398694已完成不适用
A Phase II Study Analyzing Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With 1 - 4 Brain Metastases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Rate of local control of any new, recurrent, or progressing tumors within the planning target volume
研究概览
简要总结
This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.
详细描述
Primary Objective To evaluate 6 month in-brain local control utilizing pre-operative stereotactic radiosurgery followed by surgical resection for brain metastases.
Secondary Objectives
- Overall survival
- Distant in-brain progression
- Rate of leptomeningeal spread
- Rate of radiation necrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of local control of any new, recurrent, or progressing tumors within the planning target volume
时间窗: 6 months
Measured by post-treatment MRI
次要结局
- Rate of in-brain progression free survival(6 months, 1 year, and 2 years)
- Rate of overall survival(6 months, 1 year, and 2 years)
- Proportion of patients with distant in-brain failure (any new parenchymal lesion outside of the planning target volume)(2 years)
- Proportion of patients with radiation necrosis (radiographic or biopsy-positive diagnosis of radiation necrosis)(2 years)
- Proportion of patients with leptomeningeal spread (radiographic or CSF diagnosis of leptomeningeal disease)(2 years)
研究者
Namita Agrawal
Assistant Professor of Radiation Oncology
Indiana University
研究点 (6)
Loading locations...
相似试验
招募中
2 期
Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical TrialOsteosarcomaNCT06114225Ruijin Hospital43
招募中
1 期
A phase II study of preoperative stereotactic radiation therapy boost combined with short-course immunotherapy (pembrolizumab versus placebo, randomized, double-blind) and standard chemotherapy in patients with newly diagnosed HER2-negative non-metastatic breast cancer with lack of early metabolic response in 18-fluorodeoxyglucoseFDG-PET/CT after 1st chemoterapy cycleHER2 negative breast cancerMedDRA version: 23.0Level: PTClassification code: 10083232Term: HER2 negative breast cancer Class: 100000004864CTIS2023-504145-31-00arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy78
进行中（未招募）
2 期
A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following ChemoradiationNSCLCNCT03955198Institut Claudius Regaud4
Unknown
2 期
The Combination of Fruquintinib, Tislelizumab and Stereotactic Ablative Radiotherapy in Metastatic Colorectal Cancer(RIFLE)Metastatic Colorectal CancerNCT04948034Fudan University68
Unknown
2 期
The Combination of Immunotherapy and Stereotactic Ablative Radiotherapy in MSS Oligometastatic Colorectal CancerColorectal CancerNCT04535024Fudan University60