A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Time to Cognitive Failure
研究概览
简要总结
The goal of this clinical research study is to compare IMRT with IMPT in patients with glioblastoma. Researchers want to learn about cognitive side effects (mental status changes) that may occur, such as memory loss and impaired thinking.
IMRT is the delivery of focused radiation therapy using photon beams and advanced computer planning to help shape the dose in order to give the highest possible dose to the tumor with the least dose to surrounding normal tissues.
IMPT is also focused radiation therapy similar to IMRT, but it uses proton particles to deliver the radiation instead of photon beams. IMPT also uses advanced computer planning in order to shape the dose to the target with the least dose to surrounding normal tissues.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.
If you are in Group 1, you will receive IMRT.
If you are in Group 2, you will receive IMPT.
Radiation Therapy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histological diagnosis of: Glioblastoma or Gliosarcoma (WHO Grade IV) adapted RPA class III, IV, or V.
- •All patients must be >/=18 years of age.
- •All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is the one approved by MD Anderson IRB.
- •All patients must have a baseline Mini Mental Status Examination score >/=
- •All patients must have a KPS >/=
- •All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist.
- •All patients must be able to undergo MRI with and without contrast with a glomerular filtration rate (eGFR) greater than or equal to 30 mg/min/1.72 m
- •All patients must have adequate liver, renal, and hematologic function within 14 days of registration as defined by Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline Phosphatase < 3 times normal, creatinine </=1.7 mg/dl, BUN </= 35mg/dl, absolute neutrophil count >/=1,800 cells/mm3, Hemoglobin >/= 10 g/dl, and platelet count > 100,
- •All patients must be able to adequately read, write and speak to participate in the cognitive and quality of life assessments. However mild to moderate deficits in these functions due to tumor are allowed.
排除标准
- •Patients will be excluded if they are not planning to receive concurrent temozolomide.
- •Patients will be excluded if they have had prior radiation to the brain.
- •Patients will be excluded if they have had prior surgical resection of brain for other brain tumors.
- •Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG). A serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential.
- •Patients with gliomatosis will be excluded.
- •Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded.
- •Patients weighing greater than 136 kilograms will be excluded.
结局指标
主要结局
Time to Cognitive Failure
时间窗: baseline, 4 months, then every 2 months for 2 years
Time to cognitive failure on any of 6 primary variables from pre-specified cognitive tests (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, TMT Part A or Part B, COWA) with failure defined as a decline that meets or exceeds the reliable change index (RCI) for each cognitive test variable. A cumulative incidence approach used to estimate median time to cognitive failure in order to account for the competing risks of disease progression and death.
次要结局
- Overall Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Progression Free Survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- Number of Participants Experienced Adverse Events by Maximum Grade (Grade 2 or Higher)(2 years)