A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Frequency of acute intolerable toxicities
研究概览
简要总结
This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.
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 recurrent IDH-mutant gliomas (either astrocytoma or oligodendroglioma) with prior external beam radiation therapy (EBRT) to the same region. The recurrent tumor may be either histologically confirmed or based on clinical assessment. Any number of prior recurrences is allowed.
- •Maxium tumor diameter of 7 cm or less.
- •Prior EBRT is ≥ 2 years ago.
- •The region for reirradiation should have received at least 45 Gy from the prior EBRT but no more than 75 Gy. The prior EBRT could be either photon-based or proton-based.
- •Prior SRS to the same region is permitted as long as the cumulative dose of EBRT plus SRS is no more than 75 Gy. The prior SRS should be completed at least 6 months ago.
- •Life expectancy ≥ 12 months
- •At least 18 years of age.
- •Karnofsky performance status (KPS) of at least 70%.
- •Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).
排除标准
- •Leptomeningeal or metastatic involvement.
- •Prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy.
- •Use of concurrent bevacizumab or other anti-VEGF-directed therapy during TMPRT is not allowed. If the patient is on bevacizumab, the patient needs to discontinue bevacizumab for at least 4 weeks prior to the start of TMPRT and remain stable. Other chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly at the discretion of treating physician.
- •Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
- •Pregnant.
研究组 & 干预措施
Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)
Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.
干预措施: temporally-modulated pulsed radiotherapy (TMPRT) (Radiation)
结局指标
主要结局
Frequency of acute intolerable toxicities
时间窗: From start of treatment through 3 months
Intolerable toxicities are defined as grade 3 or higher central nervous system (CNS) adverse events at least possibly related to radiation as graded by the Common Terminology Criteria for Adverse Events v5.0 with the exception of grade 3 fatigue, headache, nausea, and vomiting. Any serious adverse event leading to discontinuation of TMPRT that is at least possibly related will be considered an intolerable toxicity.
Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events
时间窗: From start of treatment through 1 year
Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
次要结局
- Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)(Assessed at approximately 3 months, 6 months, and 12 months after start of treatment)
- Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)(Assessed at approximately 3 months, 6 months, and 12 months after start of treatment)
- Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)(Assessed at approximately 3 months, 6 months, and 12 months after start of treatment)
- Number of reirradiation adverse events(From start of treatment through month 12 follow-up)
- Progression-free survival (PFS)(At one year after start of treatment)
- Overall survival (OS)(At one year after start of treatment)