Malignant Glioma
Conditions
Keywords
Hypofractionated Stereotactic Radiotherapy, Recurrent High-grade Glioma, Anlotinib
Brief summary
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.
Detailed description
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.
Interventions
Hypofractionated stereotactic radiotherapy (CyberKnife, 25Gy/5fx)
DRUGAnlotinib
Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18-70 years of age; 2. Karnofsky performance status (KPS) ≥ 60; 3. Original histopathologically proven diagnosis World Health Organization (WHO) Grade 4 glioma; 4. 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; 5. Measurable disease; 6. Estimated survival of at least 3 months; 7. 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; 8. Signed informed consent form; 9. Agreed to participate the follow-up.
Exclusion criteria
1. Prior invasive malignancy unless disease free; 2. Received re-irradiation; 3. More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter; 4. Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR; 5. Pregnancy or or nursing mothers; 6. Participated in other trials after diagnosis of recurrent; 7. Influence factors toward oral medications; 8. Patients with CTCAE5.0 grade 3+ bleeding; 9. 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%; 10. Long-term unhealed wounds or fractures; 11. History of organ transplantation; 12. Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From the start of treatment to the date of disease progression or death, up to approximately 24 months | Estimated using the Kaplan-Meier method |
| Objective response rate (ORR) | Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months | 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. |
| 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 | 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. |
| Cognitive function | Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months | 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. |
| Toxicity rate | Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 to assess the toxicity. Estimated using an exact binomial distribution together with 95% confidence interval. |
Countries
China
Outcome results
None listed