1. Progression free survival (PFS) (Time Frame - through study completion (at least 1.5 years and a maximum of 5 years) or until progression or death): Progression free survival (PFS) measured as time from the day of randomization until diagnosis of progressive disease as determined by MRI according to RANO criteria (Response Assessment in Neuro-Oncology Criteria) or death from any cause
Secondary outcome:
1. 6-month PFS rate (Time Frame - for each patient up to 6 months after randomization or until progression has occurred): Progression free survival (PFS) measured as time from the day of randomization until diagnosis of progressive disease as determined by MRI according to RANO criteria or death from any cause
2. Overall survival (OS) (Time Frame - through study completion (at least 1.5 years and a maximum of 5 years) or until death): Overall survival (OS) measured as time from the day of randomization until death
3. Progression free time (Time Frame - through study completion (at least 1.5 years and a maximum of 5 years) or until progression): Progression free time as time from the day of randomization until progressive disease (death is regarded as censored)
4. 12-month OS rate (Time Frame - for each patient up to 12 months after randomization or until death): Overall survival (OS) measured as time from the day of randomization until death
5. Absolute changes from baseline in contrast medium volume uptake from the MRI performed 48 hours after randomization on, and during any MRI performed thereafter to monitor for disease progression (Time Frame - Baseline, 26 - 48 hours after stereotactic procedure, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression, and then every 3 months until end of entire study (up to 5 years) or progression)
6. 48h response rate on MRI (Complete Remission, Partial Remission, Stable Disease) after treatment with iPDT (interstitial photodynamic therapy) (Time Frame - 26 - 48 hours after stereotactic procedure in patients treated with interstitial photodynamic therapy (iPDT)): Response is assessed according to the RANO criteria
7. If a PET (positron emission tomography) was performed less than 2 weeks apart from an MRI: Consistency of both procedures with regard to the region of interest (ROI) (Time Frame - Baseline, 26 - 48 hours after stereotactic procedure, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression and then every 3 months until end of entire study (up to 5 years) or progression)
8. Change in KPS (Karnofsky Performance Score) (Time Frame - Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression): Minimum value: 0, maximum value: 100. A higher value means a better outcome.
9. Change in NIHSS (National Institutes of Health Stroke Scale) (Time Frame - Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression): Minimum value: 0, maximum value: 42. A higher value means a worse outcome.
10. Change in MMSE (Mini-Mental State Examination) (Time Frame - Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression): Minimum value: 0, maximum value: 30. A higher value means a better outcome.
11. Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery (Time Frame - 26 to 48 hours after stereotactic intervention)
12. Frequency of Adverse Events (Time Frame - over the entire study period of each patient (at least 1.5 years and a maximum of 5 years))
13. Change in the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire) score during study participation (Time Frame - Baseline, at discharge or 7 days after intervention, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression and then every 3 months until end of entire study (up to 5 years) or progression)
14. Change in the EORTC QLQ-BN20 module (European Organisation for Research and Treatment of Cancer Quality of Life Brain Cancer Module) score during study participation (Time Frame - Baseline, at discharge or 7 days after intervention, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression and then every 3 months until end of entire study (up to 5 years) or progression)
Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid (Gliolan, 5-aminolevulinic acid): 5-ALA HCl orally (20 mg/kg bw) 3,5-4,5 hours prior to induction of anaesthesia for stereotactic biopsy followed by stereotactical photodynamic therapy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).
Stereotactic biopsy: Stereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).
Quelle: ClinicalTrials.gov
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"Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma"
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