A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
研究概览
简要总结
Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy.
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
- •Age ≥18 years;
- •Ability to express appropriate informed consent to treatment;
- •Diagnosis of cerebral glioma;
- •Histological/radiological confirmation of disease recurrence/relapse;
- •Previous brain-level radiation therapy completed a minimum of 6 months;
- •Performance status: ECOG=0-2.
排除标准
- •Refusal to radiation treatment (i.e., absence of informed consent signed);
- •Concomitant chemotherapy;
- •Leptomeningeal spread of disease and localization in both cerebral hemispheres;
- •Current pregnancy.
结局指标
主要结局
To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
时间窗: up to 5 years
Incidence of grade \>=2 brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule, defined according to CTCAE v5.0 scale
次要结局
- To assess the presence of biomarkers associated with the actinic toxicity(up to 5 years)
- To assess the presence of biomarkers associated with response to therapy(up to 5 years)
- To assess the presence of biomarkers associated with overall survival (OS)(up to 5 years)
- To assess the median survival time(up to 5 years)
- To assess the median time to local disease progression(up to 5 years)
- To assess the incidence of toxicities other than radionecrosis(up to 5 years)
- To evaluate the immunomodulation induced by the pulsed schedule in comparison with the conventional schedule(up to 5 years)