A Phase 1 Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to study if giving radiation to a brain tumor (a procedure called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep brain tissue healthy, while possibly eliminating the need to return for radiation once a patient has healed from neurosurgery. This study will also seek the best radiation dose on a brain tumor based on how well the radiation therapy works and asses the side-effects.
详细描述
Radiosurgery is a non-surgical radiation therapy that can deliver targeted radiation to small brain tumors. Radiosurgery is considered to be part of standard of care. Typically for standard of care, radiosurgery is given after a patient has healed from neurosurgery, in an attempt to destroy any cancer cells that may be left after surgery. Patients who agree to participate in this research study will receive radiosurgery before their neurosurgery.
The timing of radiosurgery (pre-operatively) and the dosing to determine the safest dose is considered experimental.
By giving radiation the typical way, after surgery, a larger area of the brain must be covered, which means healthy brain tissue also receives radiation, whereas radiation before surgery will specifically target the tumor.
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
- •Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
- •MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
- •MR evidence of at least one brain lesion ≤ 40 mm in maximal diameter that is deemed to be surgically resectable as evaluated by the neurosurgeon and appropriate for SRS. All other brain lesions must be appropriate for SRS alone and treated according to physician preference. Prior neurosurgery and/or prior SRS at a non-overlapping location are permitted at the discretion of the treating physician.
- •Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
- •Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
- •Patients aged ≥ 18 years.
- •Life expectancy ≥ 3 months
- •Non-acute KPS ≥ 60%
排除标准
- •Patients deemed medically unfit to undergo surgical resection of brain metastasis, such as those who are neurologically or hemodynamically unstable despite appropriate medical interventions.
- •Patients who have had whole brain radiation within the previous three months.
- •Patients with >4 brain metastases.
- •Active or prior: documented inherited hypersensitivity syndromes, certain autoimmune diseases, and certain collagen vascular diseases. For example, any radiation hypersensitivity syndrome, including, but not limited to, ataxia-telangiectasia, Gorlin syndrome, multiple sclerosis, scleroderma, and systemic lupus erythematosus.
- •Radiographic or cytologic evidence of leptomeningeal disease.
- •Patients receiving methotrexate, adriamycin, epirubicine, or navelbin for one week prior to or concurrently with SRS. Note: All other systemic anti-cancer therapies will be reviewed on a case-by-case basis by study PI to determine if appropriate for study treatment and documented within the research record or EMR.
研究组 & 干预措施
Neoadjuvant stereotactic radiosurgery
Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.
干预措施: Neoadjuvant stereotactic radiosurgery (Radiation)
Neoadjuvant stereotactic radiosurgery
Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.
干预措施: Neurosurgical resection (Procedure)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: 1 month after neurosurgery
To determine the maximum tolerated dose of radiosurgery given prior to neurosurgery in subjects with brain metastases of up to 4 cm.
次要结局
- Describe preliminary rates of rate of salvage treatment(3 years)
- Adverse events(1 month after neurosurgery)
- Describe preliminary rates of local tumor control(3 years)
- Describe preliminary rates of image-complete resection(3 years)
- Describe preliminary rates of leptomeningeal spread(3 years)
- Describe preliminary rates of intracranial control(3 years)
- Describe preliminary rates of progression-free survival(3 years)
研究者
Stephen Shiao
Principal Investigator; Basic Science Director, Radiation Oncology
Cedars-Sinai Medical Center