Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
研究概览
简要总结
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.
The radiation involved in this study is:
-Proton Radiation
详细描述
This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.
The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.
In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 3 years and ≤ 18 years at the time of registration
- •Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
- •Life expectancy ≥ 12 months.
- •Signed informed consent document and assent when appropriate.
- •HGB of > 10 g/L and PLT count > 80 K/uL
排除标准
- •Any prior therapeutic radiation therapy > 500 cGy has been delivered.
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
- •Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements.
- •Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
- •Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.
研究组 & 干预措施
Proton Radiotherapy
- Patients will be treated with Proton Beam once daily 5 days per week.
- Doses will be prescribed such that maximum possible coverage is achieved
干预措施: Proton Beam (Radiation)
结局指标
主要结局
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
时间窗: 3 months
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
次要结局
- Disease Free Survival(5 years)
- Early marrow changes in the vertebral bodies(2 years)
- Time to abnormality in spinal curvature(5 years)
- Pattern of Disease Relapse(2 years)
- Complete blood counts (CBC) over time(Annually for 5 years)
- Change in levels of vitamin D, calcium, and growth hormones over time(Annually for 5 years)
- Weight(Annually for 5 years)
- BMI(Annually for 5 years)
- Early marrow changes in the vertebral bodies(2 years)
- Vertebral column growth (measured by MRI) over 1 year(Last day of treatment to 1 year later)
- Change in sitting height and standing height(Annually for 5 years)
- Time to abnormality in spinal curvature(5 years)
- Disease Free Survival(5 years)
- Pattern of Disease Relapse(2 years)
- Complete blood counts (CBC) over time(Annually for 5 years)
- Change in levels of vitamin D, calcium, and growth hormones over time(Annually for 5 years)
- Weight(Annually for 5 years)
- BMI(Annually for 5 years)
研究者
Kevin X. Liu, MD, DPHIL
Principal Investigator
Massachusetts General Hospital