REMIND: An Investigator Initiated Study Testing the Feasibility of Maintenance Radiotherapy for Patients With Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number and Percentage of Participants Who Complete the Single 2 Gy Fraction of Maintenance Radiotherapy
研究概览
简要总结
REMIND is a single-center feasibility study testing maintenance radiotherapy in adult patients with newly diagnosed glioblastoma.
Participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. After enrollment, participants will enter an observational lead-in phase while receiving standard-of-care therapy off study. Approximately 4 weeks after temozolomide, participants will receive one study-specific 2 Gy fraction of maintenance radiotherapy directed at the post-operative cavity and areas of prior enhancing disease.
The study will evaluate the safety and feasibility of delivering maintenance radiotherapy. Blood samples will also be collected before and after maintenance radiotherapy to descriptively compare myeloid-derived suppressor cell frequency.
详细描述
Glioblastoma is an aggressive primary brain tumor with high rates of local recurrence despite standard treatment with surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide. This study is designed to test whether an additional single fraction of maintenance radiotherapy can be delivered safely and feasibly after standard-of-care treatment.
REMIND is a single-center investigator-initiated study enrolling adult patients with newly diagnosed glioblastoma. Eligible participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. Following enrollment, participants will enter an observational lead-in phase while receiving their prescribed standard-of-care therapy off study. During this lead-in phase, study data collection will be limited to routine electronic medical record abstraction to confirm standard-of-care treatment administration and monitor basic clinical status.
Active study participation begins approximately 2 weeks after standard-of-care treatment, when participants undergo simulation for maintenance radiotherapy. Approximately 4 weeks after temozolomide, participants will receive maintenance radiotherapy consisting of one 2 Gy fraction delivered using intensity-modulated radiotherapy directed at the post-operative cavity and areas where previous enhancing disease was identified after surgical resection.
The primary objective is to test the safety and feasibility of delivering maintenance radiotherapy. Safety will be evaluated by monitoring toxicities and adverse events, including Grade 4 or 5 toxicities related to the experimental 2 Gy radiotherapy fraction. Feasibility will be evaluated based on treatment completion. The secondary objective is to descriptively compare the frequency of myeloid-derived suppressor cells in peripheral blood before and after maintenance radiotherapy. Participants will be followed for disease response per standard of care every 2 to 4 months until death or for up to 5 years from maintenance radiotherapy.
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 diagnosis of glioblastoma according to WHO classification criteria for which standard-of-care surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide is planned
- •Planning to receive standard-of-care radiotherapy with a biological effective dose of 60 Gy or less in 30 fractions
- •Age 18 years or older at the time of consent
- •Karnofsky performance status of 70 or higher
- •Life expectancy of 3 months or longer
- •Adequate organ function confirmed by laboratory values obtained within 14 days of study enrollment, defined as absolute neutrophil count at least 1.5 × 10^9/L, platelets at least 50 × 10^9/L, and hemoglobin at least 8 g/dL independent of transfusion within 14 days of screening
- •Persons of childbearing potential or with partners of childbearing potential must be willing to use contraception during study treatment
- •Concurrent use of other investigative treatment is permitted
- •Voluntary written consent prior to the performance of any research-related activity
排除标准
- •Pregnant or breastfeeding
- •Presence of brain stem involvement within the planning target volume from the initial course of standard-of-care radiotherapy
- •Prior radiation therapy to the brain
- •Contraindication to MRI or CT
- •Uncontrolled intercurrent illness, including ongoing or active infection, hypertension, serious cardiac arrhythmia requiring medication, acute cardiovascular disease or clinically manifested myocardial insufficiency, or psychiatric illness or social situations that would limit compliance with study requirements
- •Any medical condition or clinical laboratory abnormality that, in the investigator's judgment, precludes safe participation in and completion of the study or could affect compliance with protocol conduct or interpretation of results
研究组 & 干预措施
Maintenance Radiotherapy
Participants with newly diagnosed glioblastoma will receive standard-of-care therapy off study during an observational lead-in phase, followed by one study-specific 2 Gy fraction of maintenance radiotherapy approximately 4 weeks after temozolomide.
干预措施: Maintenance Radiotherapy (Radiation)
结局指标
主要结局
Number and Percentage of Participants Who Complete the Single 2 Gy Fraction of Maintenance Radiotherapy
时间窗: From enrollment through completion of maintenance radiotherapy, approximately 4 weeks after standard-of-care temozolomide
Feasibility will be assessed by the number and percentage of enrolled participants who complete the study-specific single 2 Gy fraction of maintenance radiotherapy.
Occurrence of CTCAE Grade 4 or 5 Toxicities Related to the Single 2 Gy Maintenance Radiotherapy Fraction
时间窗: From maintenance radiotherapy through 28 days after study treatment
Safety will be assessed by the occurrence of CTCAE Grade 4 or 5 toxicities related to the experimental single 2 Gy maintenance radiotherapy fraction.
次要结局
- Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency(The frequency of myeloid-derived suppressor cells in peripheral blood will be descriptively compared before and after maintenance radiotherapy. The percentage change from pre-maintenance radiotherapy will be recorded for each participant.)