Glioma, Malignant
Conditions
Brief summary
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.
Interventions
DEVICERadiation
Intensity-modulated radiotherapy 20Gy/10fx
DRUGTemozolomide
Temozolomide 75 mg/m2 concurrently administered with RT.
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 within 14 days prior to registration; 3. Histopathologically proved diagnosis glioblastoma multiforme; 4. Underwent surgery, gross total resection or subtotal resection; 5. Estimated survival of at least 3 months; 6. 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; 7. Signed informed consent form; 8. Agreed to participate in the follow-up.
Exclusion criteria
1. Prior invasive malignancy unless disease free; 2. Received irradiation or other anti-tumor adjuvant therapies; 3. Brain stem 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 nursing mothers; 6. Participated in other trials after diagnosis; 7. Influence factors toward oral medications; 8. Patients with CTCAE5.0 grade 3+ bleeding within 4 weeks prior to registration; 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) | Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0 |
| 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