Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma.
SECONDARY OBJECTIVES:
I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients.
II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis.
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 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
- •Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
- •Patient may not receive chemotherapy concurrent with radiation
- •Signed informed consent by patient and/or parents or legal guardian
- •Lansky performance status score of 50 -100
排除标准
- •Patients with previous radiation therapy to the brain
- •Ependymoma of the spine
- •Disseminated ependymoma requiring craniospinal radiation therapy
- •Pregnancy
- •Inability to undergo MR imaging
- •Inability to receive gadolinium-based contrast agent
研究组 & 干预措施
Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
干预措施: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy (Radiation)
Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
干预措施: Quality-of-Life Assessment (Other)
Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 6 months post treatment
The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy.
次要结局
- Identify imaging biomarkers of structural and biological changes after proton therapy(Up to 24 months post-treatment)
- Quantitative image biomarkers(Up to 24 months post-treatment)
- Validity of relative biological effectiveness models(Up to 24 months post-treatment)
- Overall survival(Up to 24 months post treatment)
- Incidence of late and acute toxicities(Up to 24 months post treatment)
- Progression-free survival(Up to 24 months post treatment)
- Disease outcomes following the use of a simultaneous integrated boost(Up to 24 months post-treatment)