RecruitingNot ApplicableNCT06719440

Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

Impact of Reducing the Irradiation Volume on Survival, Toxicity, and Quality of Life in Patients With Glioblastoma Treated With Radiochemotherapy: a Prospective Multicenter Randomised Study


Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

347 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of the BELGICA trial is to evaluate if radiotherapy could be given in a more focused manner in patients with glioblastoma in order to reduce side effects and improve quality of life. The glioblastoma (GBM) is the most common and aggressive tumour originating from the brain, affecting approximately 600 patients per year in Belgium. The treatment consists in surgical resection of the tumour (when feasible), followed by a combination of radiotherapy and chemotherapy. Despite multimodal treatment (surgery, radiotherapy, and chemotherapy), the life expectancy of patients with GBM remains limited, with an average survival of 12-18 months and only 5% of patients surviving more than 5 years. In addition to limited survival, most patients with GBM experience impaired quality of life, both because of the disease and treatments. Radiotherapy is a treatment where radiation is used to kill cancer cells. In GBM, radiotherapy is targeted at the tumour (or tumour bed if the tumour was resected) with a safety margin around it (the "Clinical Target Volume" or CTV) to account for potential microscopic spread of the tumour. The downside of this safety margin is that a substantial amount of brain tissue is irradiated, which can lead to treatment toxicity. Reducing the CTV margin would enable to decrease the volume of brain being irradiated and could thereby allow to reduce the side effects of brain irradiation. The BELGICA trial (Achieving a BEtter outcome through Limiting the GlIoblastoma Clinical tArget volume) is a national multicentre trial which will evaluate if reducing the irradiation volume in glioblastoma is safe and allows for lowering side effects and improving quality of life.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a modified radiation treatment approach — targeting a smaller area of the brain around the tumor — can reduce side effects while still effectively treating glioblastoma, the most aggressive type of brain cancer. The current standard involves treating a larger area with radiation, and this study challenges that approach to improve patients' quality of life. **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with glioblastoma (confirmed by biopsy or surgical removal, using the 2021 WHO classification) - You are in reasonably good physical condition (WHO performance status 0-2) - A multidisciplinary team has confirmed that you are a candidate for combined chemotherapy and radiation - You are able to give informed consent **You may NOT be eligible if...** - You are already participating in another competing clinical trial - You have a medical reason that prevents you from having MRI scans Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy (CTV=10mm)

Radiotherapy with reduced irradiation volume CTV=10mm

RADIATIONRadiotherapy (CTV=15mm)

Radiotherapy with standard irradiation volume CTV=15mm


Locations(23)

Olv Azorg

Aalst, Belgium

EpiCURA

Baudour, Belgium

AZ Sint Jan

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

UZ Brussel

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

AZ Sint-Lucas

Ghent, Belgium

UZ Gent

Ghent, Belgium

Grand Hôpital de Charleroi

Gilly, Belgium

JESSA Ziekenhuis

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

Chu Helora

La Louvière, Belgium

UZ Leuven

Leuven, Belgium

CHU Liège

Liège, Belgium

AZ Sint Maarten

Mechelen, Belgium

Hôpital André Vésale - HUmani

Montigny-le-Tilleul, Belgium

CH Mouscron

Mouscron, Belgium

CHU UCL Namur - Sainte Elisabeth

Namur, Belgium

AZ Delta

Roeselare, Belgium

Cliniques de l'Europe

Uccle, Belgium

CHR Verviers

Verviers, Belgium

ZAS Augustinus

Wilrijk, Belgium

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NCT06719440


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