Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: A Two Arm Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Incidence of adverse events grade 3 or greater
研究概览
简要总结
This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis.
SECONDARY OBJECTIVES:
I. To evaluate the immune niche in brain metastasis following SRS in the presence of low or high dose dexamethasone.
II. To evaluate the impact of pre-operative SRS on survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18 years
- •Prior or suspected diagnosis of malignancy
- •Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Life expectancy > 12 weeks as determined by the investigator
- •Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
- •Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions
- •Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
- •Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy
排除标准
- •Patients on any immunosuppressive medication other than dexamethasone
- •Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Human immunodeficiency virus (HIV)-positive
- •Pregnant or nursing women are excluded
- •Prior whole brain radiotherapy or SRS to the same site planned for surgery
研究组 & 干预措施
Arm A (SRS, low dose dexamethasone, surgery)
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm A (SRS, low dose dexamethasone, surgery)
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
干预措施: Dexamethasone (Drug)
Arm A (SRS, low dose dexamethasone, surgery)
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
干预措施: Resection (Procedure)
Arm B (SRS, high dose dexamethasone, surgery)
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
干预措施: Resection (Procedure)
Arm B (SRS, high dose dexamethasone, surgery)
Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Incidence of adverse events grade 3 or greater
时间窗: At 4 months post-treatment
Evaluated using Common Terminology Criteria for Adverse Events. Tolerability of this regimen will be defined as \< 33% of patients develop grade \> 3 at 4 months. Adverse events will be summarized descriptively using frequencies and percentages.
次要结局
- Time to anywhere brain failure (ABF)(From preoperative SRS to intracranial progression at any site within the brain, assessed up to 2 years)
- Density of immune niche in brain metastases(Up to 2 years)
- Overall survival (OS)(From pre-operative SRS initiation to death, assessed up to 2 years)
- Time to local recurrence (LR)(From pre-operative stereotactic radiosurgery (SRS) to intracranial progression at the treated site, assessed up to 2 years)
研究者
Zachary Buchwald
Principal Investigator
Emory University