The 2021 WHO Classification of Tumors of the Central Nervous System: a summary.
David N Louis, Arie Perry, Pieter Wesseling...
https://pubmed.ncbi.nlm.nih.gov/34185076Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05331521
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
Led by University Hospital Heidelberg · Updated on 2026-02-03
406
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital Heidelberg
Lead Sponsor
U
Universitätsmedizin Mannheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating treatments for oligodendrogliomas, a type of brain tumor classified by specific genetic markers including mutations in isocitrate dehydrogenase (IDH) and co-deletion of chromosomes 1p/19q. This trial focuses on adults with newly diagnosed grade 2 or 3 gliomas, aiming to improve survival without loss of brain function, cognition, or quality of life. The study compares two treatment approaches to determine the best timing and combination of chemotherapy and radiotherapy. Participants are randomly assigned to receive either standard chemoradiation with procarbazine, CCNU (lomustine), and vincristine (PCV) combined with radiotherapy, or an experimental approach starting with chemotherapy using lomustine and temozolomide (CETEG) followed by radiotherapy and PCV at tumor progression. Radiotherapy is delivered over about 5 to 6 weeks, with doses adjusted for tumor grade. Chemotherapy cycles last 6 weeks and include specified doses of oral and intravenous drugs. During the study, participants undergo regular magnetic resonance imaging (MRI) scans every three months, neurological assessments, quality of life questionnaires, and cognitive testing annually. The main outcome measured is qualified overall survival, which tracks survival without significant cognitive or functional decline. The study lasts up to 10 years, with ongoing monitoring of tumor progression, treatment response, and patient wellbeing. Safety and side effects are carefully assessed throughout the trial.
CONDITIONS
Brief Title
A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, newly diagnosed CNS WHO grade 2 or 3 glioma
- Tumor has IDH mutation and 1p/19q co-deletion confirmed by appropriate testing
- Biopsy or resection performed with sufficient tissue for molecular analysis
- Age 18 years or older
- Karnofsky Performance Status of 60% or higher
- Life expectancy longer than 6 months
- Availability of tissue and blood samples for biomarker research
- MRI within 72 hours after surgery following guidelines
- Surgery site fully healed
- Time from surgery between 2 weeks and 3 months without prior radio- or chemotherapy
- Willing and able to complete regular neurocognitive and quality of life assessments
- Indication for postsurgical chemotherapy or toxic therapy
- Written informed consent provided
- For females with reproductive potential: negative pregnancy test before screening and agreement to use contraception during and 7 months after treatment or postmenopausal for at least 2 years
- Male participants willing to use contraception
You will not qualify if you...
- Participation in other ongoing interventional clinical trials
- Unable to undergo MRI
- Abnormal laboratory values in hematology, liver, or kidney function above grade 2 CTCAE
- Active infections like tuberculosis, HIV, Hepatitis B or C, or others posing risk to staff
- Prior anti-cancer therapy except surgery
- Immunosuppression unrelated to cancer treatment
- Other malignancies within last 5 years except certain skin cancers unless disease-free for 5 years
- Significant medical conditions that interfere with study or medication absorption
- Psychological, social, or geographical issues that could affect compliance
- Pregnancy or breastfeeding
- Known allergies to study drugs or their components
- Prolonged QTc interval over 500 ms
- Restricted medications for study drugs
- Liver disease or hepatitis as defined
- Blood clotting disorders or thrombocytopenia
- Autoimmune diseases except stable hypothyroidism and type I diabetes on stable treatment
- Recent live vaccinations
- Neuromuscular diseases like Charcot-Marie-Tooth syndrome
- Chronic constipation or subileus
- Combination treatment with mitomycin
- Hypersensitivity to dacarbazine
- Certain hereditary digestive disorders or allergies related to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 5 to 6 weeks for radiotherapy; chemotherapy cycles last 42 days each, with up to six cycles for CETEG
Participants receive initial treatment either with radiotherapy (RT) alone or with six 42-day cycles of lomustine plus temozolomide (CETEG). Radiotherapy lasts approximately 5 to 6 weeks with specific dosing depending on tumor grade. In the comparator arm, PCV chemotherapy cycles are 6 weeks long with specified dosing schedules.
Weekly visits during radiotherapy and visits every 6 weeks for chemotherapy cycles
Follow-up
Duration - Up to 10 years (120 months)
Participants are monitored regularly after treatment with MRI scans, neurological assessments, quality of life evaluations, and cognitive testing to assess brain function and tumor progression.
Visits every 3 months for MRI and assessments, annual cognitive testing
Trial Site Locations
Total: 19 locations
1
University Hospital Heidelberg, Department of Neurooncology
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
Charité, University Medicine Berlin, Neurosurgery
Berlin, Germany, 10117
Actively Recruiting
3
Knappschaftskrankenhaus Bochum GmbH, Neurology Clinic
Bochum, Germany, 44892
Actively Recruiting
4
University Hospital Bonn, Neurology Clinic
Bonn, Germany, 53127
Actively Recruiting
5
Chemnitz Hospital, Neurosurgery
Chemnitz, Germany, 09116
Actively Recruiting
6
University Hospital Cologne, Neurosurgery
Cologne, Germany, 50937
Actively Recruiting
7
University Hospital Duesseldorf, Neurooncology
Düsseldorf, Germany, 40225
Actively Recruiting
8
University Hospital Frankfurt, Neurooncology
Frankfurt, Germany, 60528
Actively Recruiting
9
University Hospital Göttingen, Neurosurgery
Göttingen, Germany, 37075
Actively Recruiting
10
University Hospital Saarland, Neurosurgery
Homburg, Germany, 66421
Actively Recruiting
11
University Hospital of Jena, Neurosurgery
Jena, Germany, 07747
Actively Recruiting
12
University Hospital Leipzig, Radiation Therapy
Leipzig, Germany, 04103
Actively Recruiting
13
University Hospital Mannheim, Neurology Clinic
Mannheim, Germany, 68167
Actively Recruiting
14
University Clinic Muehlenkreis, Minden
Minden, Germany, 32429
Actively Recruiting
15
University Hospital rechts der Isar, Radiation Oncology
Munich, Germany, 81675
Actively Recruiting
16
University Hospital Regensburg, Neurology Clinic
Regensburg, Germany, 93053
Actively Recruiting
17
Helios Hospital Schwerin, Neurosurgery
Schwerin, Germany, 19049
Actively Recruiting
18
University Hospital Tuebingen, Neurooncology
Tübingen, Germany, 72076
Actively Recruiting
19
University Hospital Wuerzburg, Neurosurgery
Würzburg, Germany, 97080
Actively Recruiting
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Research Team
W
Wolfgang Wick, Prof. Dr.
A
Antje Wick, PD Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/27370396Improvement of functional outcome for patients with newly diagnosed grade 2 or 3 gliomas with co-deletion of 1p/19q - IMPROVE CODEL: the NOA-18 trial.
A Wick, A Sander, M Koch...
https://pubmed.ncbi.nlm.nih.gov/35692047