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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intensity-modulated radiotherapy 20Gy/10fx
Hypofractionated Stereotactic Radiotherapy 30Gy/5fx
Temozolomide 75 mg/m2 concurrently administered with RT.
CyberKnife Center, Department of Neurosurgery, Huashan Hospital
Shanghai, Shanghai Municipality, China
Overall survival (OS)
Estimated using the Kaplan-Meier method
Time frame: From the start of treatment to the date of death or the last follow-up, up to approximately 24 months
Progression-free survival (PFS)
Estimated using the Kaplan-Meier method
Time frame: From the start of treatment to the date of disease progression or death, up to approximately 24 months
Objective response rate (ORR)
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Assessment in Neuro-Oncology (RANO) prior to progression or any further therapy.
Time frame: 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
Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Cognitive function
Mini-Mental State Exam (MMSE, score range 0 to 30) to evaluate the cognitive function. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months
Toxicity rate
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 to assess the toxicity. Estimated using an exact binomial distribution together with 95% confidence interval.
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Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months