NCT04197492进行中（未招募）2 期
A Phase II Study of Hypofractionated Stereotactic Radiotherapy Combined With Anlotinib in Patients With Recurrent High-Grade Glioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
A Phase II Study of Hypofractionated Stereotactic Radiotherapy (HSRT) With Anlotinib in Patients With Recurrent High-Grade Glioma. The primary endpoint is overall survival after radiotherapy. Secondary endpoints included progress-free survival, objective response rate, cognitive function, quality of life, toxicity.
详细描述
Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma patients who underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol). Recurrence based on Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathology. Intervention included CyberKnife hypofractionated stereotactic radiotherapy (25Gy/5fx) with Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years of age;
- •Karnofsky performance status (KPS) ≥ 60;
- •Original histopathologically proven diagnosis World Health Organization (WHO) Grade 4 glioma;
- •Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven;
- •Measurable disease;
- •Estimated survival of at least 3 months;
- •Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;
- •Signed informed consent form;
- •Agreed to participate the follow-up.
排除标准
- •Prior invasive malignancy unless disease free;
- •Received re-irradiation;
- •More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter;
- •Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
- •Pregnancy or or nursing mothers;
- •Participated in other trials after diagnosis of recurrent;
- •Influence factors toward oral medications;
- •Patients with CTCAE5.0 grade 3+ bleeding;
- •Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
- •Long-term unhealed wounds or fractures;
- •History of organ transplantation;
- •Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
研究组 & 干预措施
HSRT With Anlotinib
Experimental
- Hypofractionated stereotactic radiotherapy using CyberKnife 25Gy/5fx, 5 days a week for 1 week.
- Anlotinib once daily (12mg/d) orally administered on days 1-14 of a 21-day cycle until disease progression or treatment intolerance.
干预措施: Hypofractionated Stereotactic Radiotherapy (Radiation)
HSRT With Anlotinib
Experimental
- Hypofractionated stereotactic radiotherapy using CyberKnife 25Gy/5fx, 5 days a week for 1 week.
- Anlotinib once daily (12mg/d) orally administered on days 1-14 of a 21-day cycle until disease progression or treatment intolerance.
干预措施: Anlotinib (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From the start of treatment to the date of death or the last follow-up, up to approximately 24 months
Estimated using the Kaplan-Meier method
次要结局
- Progression-free survival (PFS)(From the start of treatment to the date of disease progression or death, up to approximately 24 months)
- Objective response rate (ORR)(Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months)
- Quality of Life score (QoL): European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0(Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months)
- Cognitive function(Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months)
- Toxicity rate(Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months)
研究者
Chongbo Zhao
Head of CyberKnife Center, Principal Investigator
Huashan Hospital
研究点 (1)
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