Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Cumulative Incidence of Ototoxicity
研究概览
简要总结
There are two types of external radiation treatments (proton beam and photon beam). As part of the participant's treatment, they will receive radiation to the entire central nervous system (CNS); this is known as craniospinal irradiation (CSI). In the past, photon radiation therapy has been used for CSI. In this study we will be examining the effects of proton beam radiation therapy. Studies have suggested that this kind of radiation can cause less damage to normal tissue than photon radiation therapy. The physical characteristics of proton beam radiation let the doctor safely deliver the amount of radiation delivered to the tumor that is normally delivered through standard therapy but spare more normal tissue in the process.
详细描述
- Before beginning radiation therapy, participants will have scans done in order to prepare for the radiation treatment. Doctors will use information gathered from these scans to plan the best way to deliver radiation to the tumor.
- The following procedures will be performed either before or during the radiotherapy: Hearing exam; neurocognitive exam; blood tests and cerebral spinal fluid test.
- Not everyone who participates in this study will receive the same amount of proton radiation therapy. The length of time and amount of radiation received will depend upon the condition of the participant's disease. Radiation treatment will be given once a day, 5 days a week (Monday-Friday). The overall treatment course will be approximately 6 weeks.
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 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have undergone biopsy or attempted surgical resection and must have histologically confirmed medulloblastoma or pineoblastoma.
- •Participants may have had a gross total resection, sub-total resection or biopsy only.
- •For patients with no prior chemotherapy, treatment must start within 35 days of definitive surgery or as indicated if enrolled on therapeutic study
- •Age range between 3 and 25 at the time of enrollment
- •Life expectancy of greater than 3 months
- •Blood laboratory values as outlined in the protocol
- •Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
排除标准
- •Patients with more than one previous chemotherapy regimen
- •Patients with recurrent or progressive disease after one or more regimens of pre-radiation chemotherapy
- •Patients with prior radiation therapy
- •Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements
- •Pregnant women
结局指标
主要结局
Cumulative Incidence of Ototoxicity
时间窗: 3- and 5- years post radiation treatment
Cumulative incidence (estimated percentage participants) who experienced ototoxicity defined as either grade 3 or 4 hearing loss in either ear after the completion of radiation therapy in the overall participant population. Cumulative incidence and 95% confidence intervals are shown at 3- and 5-years post RT (radiation treatment)
Neurocognitive Effects
时间窗: Baseline and Follow-up (median of 6 years)
Difference in Full-Scale Intelligence Quotient (FSIQ) between baseline and latest follow-up neurocognitive test. Tests used include WISC (Wechsler Intelligence Scale for Children) IV, WISC V, WAIS (Wechsler Adult Intelligence Scale) III, WAIS IV. The test measures the FSIQ of children through four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale with an average score of 100 and standard deviation of 15. Higher scores represent higher intelligence and lower scores represent reduced intelligence.
Endocrine Dysfunction
时间窗: 3- and 5- years post radiation treatment
Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.
次要结局
- Progression Free Survival(3- and 5-years post radiation treatment)
- Treatment Efficiency(2 years)
- Percentage of Participants Who Experienced an Acute Toxicity by Grade(3 months after radiation therapy)
研究者
Torunn Yock, MD
Director, Pediatric Radiation Oncology
Massachusetts General Hospital