NCT06397560招募中不适用
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial
Baptist Health South Florida4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.
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
- •Karnofsky performance status ≥ 50
- •Histologically-confirmed or radiographic evidence of recurrent / progressive glioma
- •Prior treatment with radiotherapy to a minimum dose of 45 Gy
- •At least 6 months or greater between completion of prior radiotherapy and enrollment in this study. If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:
- •New areas of tumor outside the original radiotherapy fields as determined by the investigator.
- •Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment.
- •Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment.
- •Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy
- •Must not be pregnant (positive pregnancy test) or breastfeeding. Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.
- •Highly effective and acceptable forms of contraception are:
- •Male condom plus spermicide
- •Cap plus spermicide
- •Diaphragm plus spermicide
- •Progesterone T
- •Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
- •Hormone shot or injection
- •Combined pill
- •Mini-pill
- •Individuals who meet any of the following criteria will not need contraception:
- •Individuals assigned male at birth
- •Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
- •Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50
- •Radiation-induced oophorectomy with last menses > 1 year ago
- •Chemotherapy-induced menopause with >1 year interval since last menses
- •Surgical sterilization (bilateral oophorectomy or hysterectomy)
排除标准
- •Two or more courses of prior radiotherapy
- •Inability to undergo an MRI with contrast
- •Leptomeningeal evidence of recurrent disease
- •Multi-focal disease
- •Any other condition that may put a participant at higher risk, at the discretion of the investigator.
研究组 & 干预措施
PRDR Radiotherapy
Experimental
干预措施: PRDR (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 3 months
PFS is defined as the duration of time from treatment start to first progressive disease (PD), date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation. Response to treatment will be assessed using Response Assessment in Neuro-Oncology (RANO).
次要结局
- Quality of life (QOL) assessed by the EuroQOL 5-dimension, 5-level (EQ-5D-5L)(1 year)
- Overall survival (OS)(2 years)
- Treatment-related adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)(2 years)
- Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT)(1 year)
- Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0(2 years)
研究者
研究点 (4)
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