Phase I/II Study of Reirradiation of Recurrent or Progressive Brainstem Glioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels
研究概览
简要总结
The goal of this clinical research study is to find a safe dose of radiation that can be given to patients with brainstem glioma who have already received radiation therapy.
You will receive photon radiation therapy. This type of radiation is similar to the radiation you have already had. Conformal radiotherapy or intensity modulated radiotherapy (IMRT) will be used to try to treat the tumor while affecting as little of the surrounding normal tissue as possible.
详细描述
Radiation Therapy Administration:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of radiation therapy based on when you join this study. Three (3) dose levels of radiation therapy will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will be randomly assigned (as in the roll of dice) to one of the dose levels, and the assignment will also depend on how the previous participants have done. Participants will not be assigned to one of the higher 2 of the 3 dose levels unless the lower dose level is found to be tolerable. The first and second groups will receive 12 treatments and the third group will receive 14 treatments (Monday through Friday for about 2½ weeks). Your doctor will tell you how many treatments you will receive.
You may be given drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.
Study Visits:
About 2-4 days before you start radiation therapy, you will have a simulation. During the simulation session, a mask will be made of your face and head to keep you still. You will also have a computed tomography (CT) scan. This process allows the radiation planning to take place. Sedation by an anesthesiologist (anesthesia doctor) will be used if needed for young children to allow the radiotherapy to be delivered safely.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DIPG by MRI imaging defined as tumor that has a pontine epicenter and is diffuse (tumor that involves the majority (>50%) of the brainstem) on T2 or FLAIR imaging rather than focal. Histologic confirmation is not required
- •Radiation therapy to brain for DIPG that was completed at least 10 months prior to planned reirradiation
- •Clinical progression of symptoms with any radiographic progression on MRI within 21 days prior to registration (any progression in size or enhancement on MRI along with worsening symptoms, will be defined as progression prior to enrollment). Radiographic progression is defined as any increase in tumor size (in axial or sagittal images) or progressive contrast enhancement and abnormal T2/FLAIR signal by MRI.
- •Signed informed consent by patient and/or parents or legal guardian
- •Lansky/Karnofsky Performance Status score of 40-100
- •Central nervous system function defined as not severely somnolent or comatose (central cortical neurotoxicity scale <Grade 3)
- •Life expectancy of >/= 8 weeks
排除标准
- •Prior radiation of greater than 60 Gy to >20% of brainstem.
- •Patients with Neurofibromatosis 1 because the biologic behavior of their tumors may be more benign
- •Asymptomatic patients because the primary goal of treatment is palliation of symptoms
结局指标
主要结局
Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels
时间窗: 1 month after radiation therapy
Optimal dose level among three RT dose levels, defined in terms of the biologically equivalent dose (BED). The BED is given by the formula BED = (Total Dose)\*(1 + d/3), denoting d = dose/fraction, with the constant 3 corresponding to brain tissue.
次要结局
未报告次要终点