Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of Short Course Radiotherapy
研究概览
简要总结
This is a single arm prospective pilot trial determining the safety of short-course radiation therapy in pediatric patients with incurable central nervous system malignancies.
详细描述
Participants will receive a shorter course of radiation therapy across 5 days (20 Gray in 5 fractions) in contrast to the standard treatment of two weeks or more of daily treatments (up to 3 Gray per day). This research study is being conducted to see if delivering a shorter course of radiation therapy is safe and helps quality of life so that it may reduce the required duration of palliative treatment.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 21 years or below
- •Lansky performance status >= 40
- •Has a diagnosis of an incurable malignancy that:
- •Originates outside the brain but is metastatic to 1 or more sites within the brain, or originates and recurs within the brain. For this diagnosis to be confirmed, there must be multidisciplinary review of up to date imaging at a pediatric tumor board with unanimous consensus of intracranial relapse or metastasis. If the consensus is not unanimous, short-interval repeat imaging with subsequent unanimous consensus would be required in order for this eligibility criteria to be met
- •Has at least 1 targetable intracranial lesion as seen on imaging
- •Has a multidisciplinary consensus recommendation for palliative intent radiation
- •Consents to the study or has caregiver who is able to provide signed and dated informed consent. For subjects under the age of 18, a signed and dated assent form as able.
- •Patients who had prior radiation in planned treatment area are also eligible to enter the trial
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Radiotherapy for curative intent
- •Serious uncontrolled systemic or psychiatric disorders that would interfere with participation in the protocol
- •Being planned for proton radiation
研究组 & 干预措施
Short Course Radiotherapy
Short-course radiation therapy in pediatric patients with incurable central nervous system malignancies
干预措施: Short Course Radiotherapy (Radiation)
结局指标
主要结局
Safety of Short Course Radiotherapy
时间窗: 1 year
The ability to complete short-course radiotherapy without grade 3 or higher adverse events (AE) that are possibly, probably, or definitely related to radiotherapy during the study period Any individual grade 3 or higher AE that is reported during the study period and deemed possibly, probably, or definitely related to short course radiotherapy will automatically prevent the study from meeting its primary endpoint.
次要结局
- Pediatric Quality of Life after Short Course Radiotherapy(1 year)
- Adolescent Quality of Life after Short Course Radiotherapy(1 year)
- Overall Survival after Short Course Radiotherapy(1 year)
- Steroid Usage(1 year)