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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Hypofractionated stereotactic radiotherapy (CyberKnife, 25Gy/5fx)
Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.
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
EORTC QLQ-C30 (version 3.0) questionnaire to evaluate the quality of life. All scales range in score from 0 to 100. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
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
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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.
Time frame: Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months