Collaborator:
Universitätsmedizin Mannheim, Ruhr University of Bochum,
Studienleiter
Wolfgang Wick, Prof. Dr. Principal Investigator University Hospital Heidelberg
Kontakt
Wolfgang Wick, Prof. Dr. Kontakt: Phone: +49 6221 56 Phone (ext.): 7075 E-Mail: wolfgang.wick@med.uni-heidelberg.de» Kontaktdaten anzeigen Antje Wick, PD Dr. Kontakt: Phone: +49 6221 56 Phone (ext.): 7075 E-Mail: antje.wick@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations (3 von 19)
University Hospital Heidelberg, Department of Neurooncology 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsCharité, University Medicine Berlin, Neurosurgery 10117 Berlin (Berlin) GermanyRekrutierend» Google-MapsKnappschaftskrankenhaus Bochum GmbH, Neurology Clinic 44892 Bochum (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps
1. Qualified overall survival (qOS) (Time Frame - From 3 months after start of treatment, every 3 months until maximum of 10 years or date of death from any cause, whichever came first.): The primary efficacy endpoint is the overall survival without functional and/or cognitive and/or quality of life deterioration over a period of 90 days, coined qualified overall survival (qOS). Short-term qOS is defined as the time from randomization to a deterioration in any of the following measures: NeuroCogFX®, KPI, HRQoL, NANO scale or death.
2. Short-term qOS deterioration in NeuroCogFX® (Time Frame - Every 12 months, after a decline within 1 week and after 90 days): A decline is a reduction in the mean percentile rank in 2 or more items (Fliessbach et al.
2010, Hoffermann et al. 2017) in two or more subset scores of established neuropsychometric test batteries determined by NeuroCogFX® (Fliessbach et al. 2010).
3. Short-term qOS deterioration in KPI (Time Frame - From 3 months after start of treatment, every 3 months until maximum of 10 years or date of death from any cause, whichever came first.): A decrease in the KPI from 100 or 90 to 70 or less, a decrease in KPI of at least 20 from 80 or less, or a decrease in KPS from any baseline to 50 or less.
Fulfilment of one of these criteria is considered neurological deterioration unless attributable to comorbid events or changes in corticosteroid dose (van den Bent et al.
2011).
4. Short-term qOS deterioration in HrQoL (Time Frame - From 3 months after start of treatment, every 3 months until maximum of 10 years or date of death from any cause, whichever came first.): A worsening of at least 10 points, which is the minimal clinically relevant difference, in at least one of the five selected domains of the HrQoL (global health status (GHS), physical functioning (PF), social functioning (SF), determined in the QLQ-C30 with higher scores indicate better HRQoL; communication deficits (CD) & motor dysfunction (MD) determined by QLQ-BN20 with lower scores indicate better HRQoL) (Taphoorn et al. 2015).
5. Short-term qOS deterioration in NANO scale (Time Frame - From 3 months after start of treatment, every 3 months until maximum of 10 years or date of death from any cause, whichever came first.): A decline in the NANO scale defined as a ≥2 level worsening from baseline within ≥1 domain or worsening to the highest score within ≥1 domain that is felt to be related to underlying tumor progression and not attributable to a comorbid event or change in concurrent medication (Nayak et al. 2017).
6. Short-term qOS deterioration due to death (Time Frame - From start of randomization until death from any cause): Death due to any cause.
Secondary outcome:
1. Short-term qOS (Time Frame - From 3 months after start of treatment until maximum of 10 years or date of death from any cause, whichever came first.): Defined as qOS as described above (deterioration in NeuroCogFX®, KPI, HRQoL, NANO scale or death) but neglecting the subsequent time interval of 3 months (90 days).
2. Overall survival (OS) (Time Frame - From start of randomization until death from any cause): Defined as the time from randomization until death due to any cause.
3. Progression-free survival (PFS) (Time Frame - From randomization until the day of first documentation of clinical or radiographic tumor progression or death of any cause, whichever occurs first): Defined as the time from randomization to the day of first documentation of clinical or radiographic tumor progression or death of any cause.
Active Comparator: RT PCV Radiotherapy (RT) for over approximately 5-6 weeks:
at 50.4/54 Gy in 1.8 Gy fractions for grade II and
at 59.4 Gy in 1.8 Gy fractions for grade III gliomas
PCV cycles are 6 weeks long and given as:
Day 1: Lomustine (CCNU) at 110 mg/m2 body surface orally,
Days 8/29: Vincristine 1.4 mg/m2 i.v. (capped at 2 mg),
Days 8-21: Procarbazine 60 mg/m2 orally (capped at 100 mg).
Experimental: CETEG Six 42-day cycles of lomustine plus temozolomide according to the commonly used regimen:
Day 1: Lomustine (CCNU) at 100 mg/m2
Days 2-6: Temozolomide at 100 mg/m2 (cycles 1) and in 50 mg/m2 steps to 200 mg/m2 from cycle 2 on dependent on hematological toxicity
CETEG (Lomustine (CCNU) and Temozolomide): At progression, patients without prior radiotherapy will undergo radiotherapy and PCV as an adjunct chemotherapy if bone marrow reserve allows in the experimental arm.
PCV (Procarbazine, Lomustine and Vincristine): In the comparator arm there is the option for second radiotherapy or even reuse of the full radiochemotherapy regimen as it had been given at diagnosis (BIC).
RT (Radiotherapy): Radiotherapy at 50.4/54 Gy in 1.8 Gy fractions for grade II and 59.4 Gy in 1.8 Gy fractions for grade III gliomas
Quelle: ClinicalTrials.gov
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"A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas)."
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