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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 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
- •Radiographically confirmed solid tumor brain metastases
- •Criteria for surgical resection of at least one metastasis per neurosurgeon discretion
- •A diagnostic MRI Brain or CT Head demonstrating the presence of 1-4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. If multiple lesions are present, then the total brain metastases volume can be no more than 30 cm3 excluding the lesion to be resected.
- •For known primary included in brainmetgpa.com, an estimated median survival no less than 6 months per brainmetgpa.com
- •For unknown primary or known primary not included within brainmetgpa.com, an estimated median survival no less than 6 months per PI discretion Note: If patient's estimated median survival is calculated using a histology that is different than the histology demonstrated in final pathology, the patient may remain eligible for all study endpoints per PI discretion
- •Surgical candidate per neurosurgeon discretion
- •Surgical resection able to be performed within 1 - 4 days after radiosurgery
- •Stereotactic radiosurgery candidate per radiation oncologist
- •≥ 18 years old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization. This will be assessed by the consenting physician using general questions to determine the patient's ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choices.
- •Platelet count > 100 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm
- •Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-VEGF therapy
- •If a patient who meets all stated eligibility criteria is enrolled on study and then discovered to be ineligible, the tissue obtained will still be deemed eligible to remain in study for evaluation.
排除标准
- •Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection
- •Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up
- •Patients with more than 4 brain metastases on MRI Brain or CT Head
- •Lesion to be resected is more than 5 cm
- •Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected
- •Patients with leptomeningeal metastases documented by MRI or CSF evaluation
- •Previous whole brain radiation therapy
- •Previous radiation therapy to lesion to be resected
- •Planned adjuvant focal therapy including additional radiation therapy to the brain
- •Not a surgical candidate per neurosurgeon's discretion
- •Not a radiosurgical candidate per radiation oncologist's discretion
- •Surgery unable to be performed between 1 - 4 days after radiosurgery
- •Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child
研究组 & 干预措施
Arm 1
Experimental
This is a single arm study so this arm will include all eligible subjects. All subjects will have radiosurgery 1-4 days prior to surgical resection.
干预措施: Radiosurgery (Procedure)
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 (3)
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