Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Proportion of participants without local failure (Phase II)
研究概览
简要总结
This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)
II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)
SECONDARY OBJECTIVES:
I. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.
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
- •Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- •Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
- •Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
- •Patient must have a Karnofsky performance score of ≥ 70
排除标准
- •Patient deemed medically unfit to undergo surgical resection of brain metastasis
- •Prior whole brain radiotherapy
- •Patient with contraindication for imaging with MRI
- •Inability to participate in study activities due to physical or mental limitations
- •Inability or unwillingness to return for all the required follow-up visits
- •At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
- •Tumor located in the brainstem
- •Imaging or cytologic evidence of leptomeningeal disease
研究组 & 干预措施
Treatment (radiosurgery, surgery)
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
干预措施: radiosurgery (Radiation)
Treatment (radiosurgery, surgery)
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
干预措施: therapeutic conventional surgery (Procedure)
Treatment (radiosurgery, surgery)
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Proportion of participants without local failure (Phase II)
时间窗: Up to 3 years
Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.
Maximum tolerated dose (MTD)
时间窗: Day 0
MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
次要结局
- Proportion of participants with distant brain failure(Up to 3 years)
- Rate of salvage treatment(Up to 3 years)
- Rate of radiation necrosis/steroid dependency(Up to 3 years)