Mathematical Model-Adapted Radiation Fractionation Schedule for Patients With Recurrent Glioblastoma (MARS-Glio)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of Participants to Complete Model Adapted Radiations Fractionation Scheduled
研究概览
简要总结
This research study is studying a new schedule of radiation therapy for recurrent glioblastoma as a possible treatment for this diagnosis. This radiation schedule is based on a new model for radiation resistance in glioblastoma.
The name of the radiation schedule involved in this study is:
- Re-irradiation for glioblastoma using a novel Mathematical Model-Adapted Radiation Fractionation Schedule
详细描述
This research study is a Feasibility Study, which means that this is the first time that investigators are examining this new radiation schedule for recurrent glioblastoma.
- The FDA (the U.S. Food and Drug Administration) has approved radiation therapy as a treatment option for your disease.
- This is the first time that this particular radiation schedule will be tested in humans. There many other studies which have tested different radiation schedules in glioblastoma.
In this research study, investigators are adapting a standard two-week schedule of radiation commonly used for recurrent glioblastoma using a mathematical model. This study uses the same total dose of radiation as standard treatments but breaks up the dose into different amounts daily to maximize tumor kill. investigators have used a new mathematical model to create this schedule of radiation. This model was created to better represent how glioblastoma cells can escape the damaging effects of radiation. Based on the results of several laboratory studies, it is possible that this model may result in improved outcomes compared to standard radiation schedules.
The primary question of this study is to see whether participants can complete this new radiation schedule at the scheduled times. In addition, investigators will follow participants to ensure that this treatment is safe. If this treatment proves feasible, investigators hope to compare this treatment directly with standard radiation schedules for newly diagnosed and recurrent glioblastoma.
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
- •Participants must have recurrent glioblastoma (WHO Grade IV), as defined on brain imaging with CT or MRI, after prior receipt of definitive therapy including neurosurgical biopsy or resection and radiation therapy with or without systemic therapy.
- •Participants must be deemed appropriate candidates for re-irradiation
- •Histopathologic confirmation of disease as part of routine clinical care is required either at the time of initial diagnosis and/or at the time of recurrent disease. There is no requirement for central pathologic review.
- •Age ≥ 18 years at the time of enrollment
- •Karnofsky Performance Status (KPS) of at least 70
排除标准
- •Participants who have received more than one prior course of radiotherapy to the local site of progressive disease
- •Participants who have received prior radiotherapy to the local site of progressive disease within < 3 months of the anticipated start of re-irradiation
- •Participants with recurrent tumor extensively abutting or involving the optic structures or brainstem, as assessed by the treating radiation oncologist
- •Participants without a definable tumor cavity on MRI or CT obtained at study enrollment
- •Participants receiving concurrent cytotoxic chemotherapy (i.e. temozolomide, CCNU, vincristine, procarbazine) or concurrent immunotherapy (i.e. pembrolizumab, nivolumab); however, participants may receive sequential chemotherapy before or after radiation without limitation. Participants may receive concurrent corticosteroid and/or anti-angiogenic therapy (i.e. bevacizumab) if clinically indicated.
研究组 & 干预措施
Mathematical Model-Adapted Radiation
Mathematical Model-Adapted Radiation Fractionation Schedule
干预措施: Mathematical Model-Adapted Radiation Fractionation Schedule (Radiation)
结局指标
主要结局
Number of Participants to Complete Model Adapted Radiations Fractionation Scheduled
时间窗: 10 Days
Successful completion of radiotherapy is defined as receipt of all scheduled fractions of daily radiotherapy within 24 hours of once daily fractions and within 1 hour of three-times daily fractions.
次要结局
- Median Progression-Free Survival (PFS)(Disease evaluated on visit 4,5,6 and every 2-4 months in long-term. The range of follow-up from date of registration was 1.2 - 38.6 months and the median was 7.3 months.)
- Grade 3-5 Treatment-related Toxicity Rate(6 Months)
- Number of Participants Receiving Additional Systemic Treatments After Reirradiation(6 Months)
- Number of Participants With Radiation Necrosis(6 months)
- Number of Participants With Seizures(6 months)
- Overall Survival (OS)(range of follow-up from date of registration was 1.2 - 38.6 months)
- Number of Participants Undergoing Salvage Craniotomy(6 Months)
- Median Local Recurrence-free Survival(Disease evaluated on visit 4,5,6 and every 2-4 months in long-term. The range of follow-up from date of registration was 1.2 - 38.6 months and the median was 7.3 months.)
研究者
Shyam Tanguturi, MD
Principal Investigator
Dana-Farber Cancer Institute