Recruiting

ImproveCodelCETEG and Partial Brain Radiotherapy for Newly Diagnosed Grade 2/3 Glioma with 1p/19q Co-deletion

Study Aim

This phase 3 study aims to evaluate the effectiveness of CETEG and partial brain radiotherapy in improving qualified overall survival (qOS) for newly diagnosed grade 2/3 glioma patients with 1p/19q co-deletion, focusing on overall survival without functional, cognitive, or quality of life deterioration over a period of 90 days.

What is being tested

CETEG

+ PCV

+ RT

DrugRadiation

Who is being recruted

Glioma+6

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years

+39 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 2021

See protocol details

Summary

Principal SponsorUniversity Hospital Heidelberg

Study ContactWolfgang Wick, Prof. Dr.More contacts

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 7, 2021

Actual date on which the first participant was enrolled.

This study, known as the NOA-18/IMPROVE CODEL trial, focuses on patients newly diagnosed with a specific type of brain tumor called Grade 2 or 3 Glioma. This tumor has a unique characteristic known as co-deletion of 1p/19q. The main goal is to evaluate if starting treatment with a chemotherapy combination called CETEG, followed by partial brain radiotherapy (RT) and another chemotherapy combination PCV (RT-PCV) at progression, is better than the current standard approach. The standard approach involves partial brain radiotherapy (RT), followed by PCV chemotherapy (RT-PCV), and the best treatment choice by the investigator at progression. The study aims to improve the quality of life and cognitive abilities of patients, addressing the current challenges in treating this condition. During the trial, participants will undergo assessments every 3 months, including MRI scans, neurological evaluations using the NANO scale, quality of life assessments, and Karnofsky performance status evaluations. Annual cognitive tests will also be conducted. The study measures the results by looking at the overall survival without a decline in functional, cognitive, or quality of life over 90 days, referred to as qualified overall survival (qOS). Secondary outcomes include evaluating short-term qOS, progression-free survival (PFS), overall survival (OS), and response rates to treatment. The trial is planned to take place at 21 study sites in Germany.

Official TitleImprovement 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

NCT05331521

Principal SponsorUniversity Hospital Heidelberg

Study ContactWolfgang Wick, Prof. Dr.More contacts

Last updated: February 4, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

406 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

GliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueOligodendrogliomaNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

16 inclusion criteria required to participate

Histologically confirmed, newly diagnosed CNS WHO grade 2 or 3 glioma.

Age: ≥18 years.

Availability of formalin-fixed paraffin-embedded (FFPE) or fresh-frozen tissue and ethylenediamine tetraacetic acid (EDTA) blood for biomarker research.

Male patients are willing to use contraception

Show More Criteria

23 exclusion criteria prevent from participating

Liver disease characterized by: ALT or AST (≥ Grade 2 CTCAE v5.0) confirmed on two consecutive measurements OR Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices (≥ Grade 2 CTCAE v5.0) OR Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis.

Known uncorrected coagulopathy, platelet disorder, or history of non-drug induced thrombocytopenia.

History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; autoimmune-related hypothyroidism (patients on a stable dose of thyroid replacement hormone are eligible for this study) and type I diabetes mellitus (patients on a stable dose of insulin regimen are eligible for this study).

Vaccination with life vaccines during treatment and 4 weeks before start of treatment.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

Radiotherapy (RT) for over approximately 5-6 weeks: * at 50.4/54 Gy in 1.8 Gy fractions for grade 2 and * at 59.4 Gy in 1.8 Gy fractions for grade 3 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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Recruiting

University Hospital Heidelberg, Department of Neurooncology

Heidelberg, GermanyOpen University Hospital Heidelberg, Department of Neurooncology in Google Maps

Recruiting

Charité, University Medicine Berlin, Neurosurgery

Berlin, Germany

Recruiting

Knappschaftskrankenhaus Bochum GmbH, Neurology Clinic

Bochum, Germany

Recruiting

University Hospital Bonn, Neurology Clinic

Bonn, Germany

Recruiting

19 Study Centers