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A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).
Sponsor: University Hospital Heidelberg
Summary
Oligodendrogliomas in the novel edition of the Central Nervous System (CNS) World Health Organization (WHO) classification are now molecularly defined by isocitrate dehydrogenase (IDH)1 or IDH2 mutations and 1p/19q co-deletion. The prognosis of these molecularly defined tumors is to be determined in new series since survival data from older histology-based studies and population-based registries are confounded by the inclusion of 20-70% not molecularly matching subsets. Also, the optimal treatment is a matter of ongoing investigations. An extensive, but safe surgery is associated with improved outcome as is the addition of chemotherapy with procarbazine, CCNU (lomustine), and vincristine (PCV) to the partial brain radiotherapy (RT). However, the exact timing of postsurgical therapy especially for tumors of the WHO grade 2 and acknowledging some variability in grading as well as the choice of chemotherapy, temozolomide instead of PCV (CODEL: NCT00887146 randomizing CNS WHO grade 2 and 3 oligodendrogliomas to chemoradiation(CHRT)therapy with PCV or with temozolomide) or the need for primary radiotherapy RT are subjects of clinical studies (POLCA: NCT02444000 randomizing patients with newly diagnosed CNS WHO grade 3 oligodendrogliomas to standard CHRT with PCV or PCV alone). Given the young age of patients with CNS WHO grade 2 and 3 oligodendrogliomas and the relevant risk of neurocognitive, functional and quality-of-life impairment with the current aggressive standard of care treatment, chemoradiation with PCV, of the tumor located in the brain optimizing care is the major challenge. NOA-18/IMPROVE CODEL aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG), thereby delaying radiotherapy (RT) and adding the chemoradiotherapy (CHRT) concept at progression after initial radiation-free chemotherapy, allowing for an effective salvage treatment and delaying potentially deleterious side effects. QOS represents a new concept and is defined as OS without functional and/or cognitive and/or quality of life (QOL) deterioration regardless whether tumor progression or toxicity is the main cause.
Official title: Improvement of Functional Outcome for Patients With Newly Diagnosed Grade 2 or 3 Glioma With Co-deletion of 1p/19q - IMPROVE CODEL: the NOA-18 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
406
Start Date
2021-04-07
Completion Date
2033-03-31
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
CETEG
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
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 at 50.4/54 Gy in 1.8 Gy fractions for grade 2 and 59.4 Gy in 1.8 Gy fractions for grade 3 gliomas
Locations (19)
University Hospital Heidelberg, Department of Neurooncology
Heidelberg, Baden-Wurttemberg, Germany
Charité, University Medicine Berlin, Neurosurgery
Berlin, Germany
Knappschaftskrankenhaus Bochum GmbH, Neurology Clinic
Bochum, Germany
University Hospital Bonn, Neurology Clinic
Bonn, Germany
Chemnitz Hospital, Neurosurgery
Chemnitz, Germany
University Hospital Cologne, Neurosurgery
Cologne, Germany
University Hospital Duesseldorf, Neurooncology
Düsseldorf, Germany
University Hospital Frankfurt, Neurooncology
Frankfurt, Germany
University Hospital Göttingen, Neurosurgery
Göttingen, Germany
University Hospital Saarland, Neurosurgery
Homburg, Germany
University Hospital of Jena, Neurosurgery
Jena, Germany
University Hospital Leipzig, Radiation Therapy
Leipzig, Germany
University Hospital Mannheim, Neurology Clinic
Mannheim, Germany
University Clinic Muehlenkreis, Minden
Minden, Germany
University Hospital rechts der Isar, Radiation Oncology
Munich, Germany
University Hospital Regensburg, Neurology Clinic
Regensburg, Germany
Helios Hospital Schwerin, Neurosurgery
Schwerin, Germany
University Hospital Tuebingen, Neurooncology
Tübingen, Germany
University Hospital Wuerzburg, Neurosurgery
Würzburg, Germany