NCT00681473已完成不适用
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Late Effects > 3 Months Post RT
研究概览
简要总结
In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.
详细描述
- Participants will receive radiation therapy for 6 weeks, given in daily doses, Monday through Friday, for a total of 30 treatments.
- A medical history and physical examination will be performed prior to the start of radiation treatment, weekly during the 6 weeks of radiation and after the finish of radiation performed at 3 and 6 months and then annually for 5 years.
- Hormonal function tests will be taken prior to the start of radiation treatment and after the finish of radiation treatment at 3 and 6 months, and annually for five years to assess the participants hormonal functions as they relate to the pituitary gland's function.
- A brain MRI will be performed prior to the start of radiation treatment and then performed at 3 and 6 months after radiation treatment then annually for 5 years.
- A neurocognitive exam will be performed prior to the start of radiation therapy, a limited exam 6 months after the completion of radiation therapy, and a complete exam annually for 5 years.
- Quality of Life and Emotional Well-Being Questionnaires will be done before radiation begins, 2 months after radiation treatment, 6 months after radiation treatment and then annually for 5 years.
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
- •Histologically confirmed low-grade gliomas, WHO classification II/IV or equivalent low grade histology, including protoplasmic, fibrillary, gemistocytic astrocytomas, and mixed variants such as oligoastrocytomas
- •Must have at least one of: (1) progressive or recurrent disease as defined by imaging, (2) persistence or progression of debilitating neurological symptoms, or (3) at risk of early progression as defined by either (a) age of 40 or older or (b) MIB-1 of 3% or greater
- •KPS of 70 or greater
- •18 years of age or older
- •Surgical and medical/chemotherapeutic interventions are per physician's discretion and are acceptable
- •Must be able to speak and comprehend English
排除标准
- •Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, CVA, TIA, or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, HIV positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
- •Prior history of cranial irradiation
- •Pregnancy at the time of radiation treatment
- •Unable to undergo MRI scans (e.g., embedded ferromagnetic metal or pacemakers)
- •Comorbid illness or reason to suggest a life expectancy of less than 5 years
结局指标
主要结局
Number of Participants With Late Effects > 3 Months Post RT
时间窗: 5 years
次要结局
- Percentage of Participants With Progression Free Survival(At 1, 3, and 5 years)
- Percentage of Participants With Overall Survival(At 1, 3, and 5 years)
研究者
Helen A. Shih, MD
Attending Radiation Oncologist
Massachusetts General Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and NeckCentral Nervous System TumorsNCT01067196University of Florida500
已完成
不适用
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate CancerProstate CancerNCT01040624University of Florida77
已完成
不适用
Proton Therapy for Unresectable Cancer (CA) of PancreasPancreatic CancerNCT00685763University of Florida13
已完成
2 期
Postoperative Proton Radiotherapy With Chemo for Pancreatic CancerPancreatic CancerNCT01553019University of Florida2
已完成
不适用
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and CholangiocarcinomaLiver CancerNCT00976898Massachusetts General Hospital83