First recurrence glioblastoma
Conditions
Brief summary
Overall survival (OS), defined as the time from the date of randomization to the date of death due to any cause or censored at the time of last follow-up, calculated according to the Kaplan Meier method.
Detailed description
Tumor Growth Rate Tumor Growth Rate will be determined by measuring hyperintense tumor volume using T1w contrast-enhancing tumor-related region from post-surgery MRI baseline to unequivocal progression MRI (i.e., suspected radiologic progression confirmed by repeat scan) or W20-22 MRI whichever comes first, Progression Free Survival (PFS) Progression-free survival is defined as the time from randomization date to the earlier of the following events: unequivocal tumor progression as determined per RANO criteria or death due to any cause, Frequency and severity of adverse events scored according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, from surgery to End-of-Trial Intervention visit, Overall survival at 9, 12, 18 and 24 months defined as rate of patients alive at 9 and 24 months (OS9, OS12, OS18, OS24), Response rate (in patients with evaluable disease, per RANO criteria), Rate of patients who are progression-free at 3, 6 and 9 months (PFS3, PFS6, PFS9), Patient Reported Outcome will be assessed using the EQ-5D-5L, the EORTC QLQ-C30, and the EORTC QLQ-BN20 quality of life questionnaires at inclusion (baseline), 6 and 12 weeks after start of treatment as well as End-of-Trial Intervention visit. Patient Reported Outcome will be collected in all patients, irrespective of treatment arm and irrespective of subsequent line therapy initiated in the meantime.
Interventions
DRUGTEMOZOLOMIDE
DRUGLOMUSTINE
Sponsors
Carthera, Carthera
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time from the date of randomization to the date of death due to any cause or censored at the time of last follow-up, calculated according to the Kaplan Meier method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor Growth Rate Tumor Growth Rate will be determined by measuring hyperintense tumor volume using T1w contrast-enhancing tumor-related region from post-surgery MRI baseline to unequivocal progression MRI (i.e., suspected radiologic progression confirmed by repeat scan) or W20-22 MRI whichever comes first, Progression Free Survival (PFS) Progression-free survival is defined as the time from randomization date to the earlier of the following events: unequivocal tumor progression as determined per RANO criteria or death due to any cause, Frequency and severity of adverse events scored according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, from surgery to End-of-Trial Intervention visit, Overall survival at 9, 12, 18 and 24 months defined as rate of patients alive at 9 and 24 months (OS9, OS12, OS18, OS24), Response rate (in patients with evaluable disease, per RANO criteria), Rate of patients who are progression-free at 3, 6 and 9 months (PFS3, PFS6, PFS9) | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden
Outcome results
None listed