Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases: A Single Arm, Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Death due to progressive neurologic disease
研究概览
简要总结
This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases.
The intervention involved in this study is:
-Stereotactic (focused, pinpoint) radiation
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment, in this case stereotactic radiation, to learn whether this treatment works in treating a specific disease. "Investigational" means that the treatment is being studied.
In patients with a limited number of brain metastases (spread of a cancer that started outside of the brain to the brain itself) the standard radiation option is stereotactic radiation, which involves using a high dose of radiation that only targets the specific metastases that are visible on imaging of the brain, not the whole brain itself. However, studies evaluating the role of stereotactic radiation to treat brain metastases generally excluded patients with small cell lung cancer. Therefore, among patients with small cell lung cancer and brain metastases, the typical treatment that has been offered is whole brain radiation. However, whole brain radiation has deleterious associated side effects including significant fatigue and permanent memory/attention problems. The investigators are studying whether stereotactic radiation can be effectively utilized for patients with small cell lung cancer and brain metastases in order to avoid such side effects.
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
- •Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible. Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study.
- •1-10 definitive intracranial lesions must be present on MRI of the brain.
- •Age >=18 years at diagnosis of brain metastases.
排除标准
- •Participants who have undergone prior radiation for brain metastases.
- •Participants who have received prophylactic cranial radiation for prevention of brain metastases
- •Participants who cannot receive gadolinium
- •Participants with stage IV-V chronic kidney disease or end stage renal disease
- •Participants with widespread, definitive leptomeningeal disease
- •Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
- •Participants with >6 definitive lesions consistent with brain metastases
- •Participants with inadequate mental capacity to complete quality of life questionnaires
研究组 & 干预措施
Stereotactic Radiation
- Stereotactic radiation will begin within 14 days of the MRI used for radiation planning
- Lesions <2 cm in maximum diameter will be treated with stereotactic radiosurgery, generally 20 Gy in 1 fraction
- Lesions between 2.0 and 3.0 cm in maximum diameter will generally be treated to 18 Gy in 1 fraction
- Lesions >3 cm will be generally be treated with stereotactic radiotherapy to 30 Gy in 5 fractions
干预措施: Stereotactic Radiation (Radiation)
结局指标
主要结局
Death due to progressive neurologic disease
时间窗: 12 months
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)
Neurologic Mortality
时间窗: 12 months
Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic progressive disease).
次要结局
- Incidence and time to detection of new brain metastases(Until death or loss to follow up, up to 24 months)
- Performance status(Until death or loss to follow up, up to 24 months)
- Incidence and time to salvage craniotomy(Until death or loss to follow up, up to 24 months)
- All-cause mortality(Until death or loss to follow up, up to 24 months)
- Neurocognitive function: Verbal fluency(12 months)
- Incidence and time to local recurrence of existing brain metastases(Until death or loss to follow up, up to 24 months)
- Quality of life as assessed by patient Questionnaire(Until death or loss to follow up, up to 24 months)
- Neurocognitive function: Visual attention and task switching(12 months)
- Incidence and time to development of radiation necrosis(Until death or loss to follow up, up to 24 months)
- Incidence and time to progressive intracranial disease(Until death or loss to follow up, up to 24 months)
- Incidence and time to additional CNS-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course(Until death or loss to follow up, up to 24 months)
- Incidence and time to the development of seizures(Until death or loss to follow up, up to 24 months)
- Neurocognitive function: Verbal learning and memory(12 months)
- Neurocognitive function: Cognitive impairment(12 months)
- Ability to complete activities of daily living(Until death or loss to follow up, up to 24 months)
- Incidence and time to development of leptomeningeal disease(Until death or loss to follow up, up to 24 months)
- All-cause Mortality(Until death or loss to follow up, up to 24 months)
- Quality of Life as Assessed by Patient Questionnaire(Until death or loss to follow up, up to 24 months)
- Neurocognitive Function: Verbal Learning and Memory(12 months)
- Neurocognitive Function: Visual Attention and Task Switching(12 months)
- Neurocognitive Function: Verbal Fluency(12 months)
- Neurocognitive Function: Cognitive Impairment(12 months)
- Ability to Complete Activities of Daily Living(Until death or loss to follow up, up to 24 months)
- Performance Status(Until death or loss to follow up, up to 24 months)
- One and Two Year Incidence of New Brain Metastases(Until death or loss to follow up, up to 24 months)
- Incidence of Existing Brain Metastases(Until death or loss to follow up, up to 24 months)
- Incidence of Development of Radiographic Radiation Necrosis(Until death or loss to follow up, up to 24 months)
- Incidence of Development of Leptomeningeal Disease(Until death or loss to follow up, up to 24 months)
- Incidence of Salvage Craniotomy(Until death or loss to follow up, up to 24 months)
- Incidence of Additional CNS-directed Radiotherapeutic Treatments (Stereotactic Radiation) After the Initial Course(Until death or loss to follow up, up to 24 months)
- Incidence of Seizures(Until death or loss to follow up, up to 24 months)
- Incidence of Symptomatic Radiation Necrosis(Until death or loss to follow up, up to 24 months)
- Incidence of Neurologic Death at 2 Years(2-years)
- Incidence of Additional CNS-directed Radiotherapeutic Treatments (Whole Brain Radiation) After the Initial Course(Until death or loss to follow up, up to 24 months)
研究者
Ayal A. Aizer, MD
Principal Investigator
Brigham and Women's Hospital