NCT04547621Unknown1 期
The Combination of Hypofractionated Stereotactic Radiotherapy and Chemoradiotherapy Using Intensity-Modulated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme: A Prospective, Single-Center, Single-Arm Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of the combination of 30Gy/5fx HSRT and 20Gy/10fx IMRT adjuvant therapy. The total biological effective dose (BED) of the PTV is 72 Gy in a ratio of alpha/beta ratio of 3, which equals to the conventional 60Gy/30fx treatment. This study can provide evidence for future non-inferiority phase III randomized controlled trials. The abbreviated course of radiotherapy can reduce the treatment time by half, benefit patients, and utilize the health resource.
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 within 14 days prior to registration;
- •Histopathologically proved diagnosis glioblastoma multiforme;
- •Underwent surgery, gross total resection or subtotal resection;
- •Estimated survival of at least 3 months;
- •Hgb > 90/gL; absolute neutrophil count (ANC) > 1.5×109/L, platelets > 80×109/L; 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 in the follow-up.
排除标准
- •Prior invasive malignancy unless disease free;
- •Received irradiation or other anti-tumor adjuvant therapies;
- •Brain stem 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 nursing mothers;
- •Participated in other trials after diagnosis;
- •Influence factors toward oral medications;
- •Patients with CTCAE5.0 grade 3+ bleeding within 4 weeks prior to registration;
- •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+IMRT+Temozolomide
Experimental
- Intensity-modulated radiotherapy 20Gy/10fx, 5 days a week for 2 weeks.
- Hypofractionated stereotactic radiotherapy 30Gy/5fx, 5 days a week for 1 week.
- Temozolomide once daily (75mg/m2/d) orally administered concurrently with radiotherapy.
干预措施: Radiation (Device)
HSRT+IMRT+Temozolomide
Experimental
- Intensity-modulated radiotherapy 20Gy/10fx, 5 days a week for 2 weeks.
- Hypofractionated stereotactic radiotherapy 30Gy/5fx, 5 days a week for 1 week.
- Temozolomide once daily (75mg/m2/d) orally administered concurrently with radiotherapy.
干预措施: Temozolomide (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)(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
研究点 (1)
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