What is this study trying to find out about oligodendroglioma?

This study is evaluating different treatment approaches for adults with newly diagnosed grade 2 or 3 oligodendrogliomas, focusing on improving survival without loss of brain function, cognition, or quality of life. It compares standard chemoradiation to a chemotherapy-first method followed by radiotherapy at progression. The goal is to find a treatment that maintains quality of life while effectively managing the tumor.

Who may be eligible for this oligodendroglioma clinical trial?

Adults aged 18 years or older with newly diagnosed grade 2 or 3 gliomas carrying specific genetic markers (IDH mutation and 1p/19q co-deletion) may be eligible. Participants must have a good performance status and life expectancy over 6 months. Anyone who has had prior anti-cancer therapy other than surgery is excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this oligodendroglioma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05331521

Improving Brain Function and Quality of Life in Adults with Newly Diagnosed Grade 2 or 3 Gliomas Having 1p19q Co-deletion

Led by University Hospital Heidelberg · Updated on 2026-02-03

406

Participants Needed

Research Sites

N/A

Total Duration

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 1p19q. 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

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