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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants capable of giving informed consent

• Age \>= 18 y.o.

• WHO performance status 0-2

• Newly diagnosed glioblastoma (Histologically proven glioblastoma per WHO 2021 classification based on biopsy or resection )

• Indication of chemoradiotherapy confirmed by multidisciplinary tumour board

Locations
Other Locations
Belgium
Olv Azorg
NOT_YET_RECRUITING
Aalst
EpiCURA
NOT_YET_RECRUITING
Baudour
AZ Sint Jan
NOT_YET_RECRUITING
Bruges
Cliniques universitaires Saint-Luc
RECRUITING
Brussels
Institut Jules Bordet
NOT_YET_RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
Ziekenhuis Oost-Limburg (ZOL)
NOT_YET_RECRUITING
Genk
AZ Sint-Lucas
NOT_YET_RECRUITING
Ghent
UZ Gent
NOT_YET_RECRUITING
Ghent
Grand Hôpital de Charleroi
NOT_YET_RECRUITING
Gilly
JESSA Ziekenhuis
NOT_YET_RECRUITING
Hasselt
AZ Groeninge
RECRUITING
Kortrijk
Chu Helora
NOT_YET_RECRUITING
La Louvière
UZ Leuven
NOT_YET_RECRUITING
Leuven
CHU Liège
NOT_YET_RECRUITING
Liège
AZ Sint Maarten
NOT_YET_RECRUITING
Mechelen
Hôpital André Vésale - HUmani
NOT_YET_RECRUITING
Montigny-le-tilleul
CH Mouscron
NOT_YET_RECRUITING
Mouscron
CHU UCL Namur - Sainte Elisabeth
NOT_YET_RECRUITING
Namur
AZ Delta
RECRUITING
Roeselare
Cliniques de l'Europe
NOT_YET_RECRUITING
Uccle
CHR Verviers
NOT_YET_RECRUITING
Verviers
ZAS Augustinus
NOT_YET_RECRUITING
Wilrijk
Contact Information
Primary
Dario Di Perri, MD
dario.diperri@saintluc.uclouvain.be
+32 2 764 47 52
Backup
Chloë De Laet
Belgica.kce@saintluc.uclouvain.be
+32 2 764 82 75
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2031-10
Participants
Target number of participants: 347
Treatments
Active_comparator: Standard of Care
Experimental: Interventional arm
Sponsors
Collaborators: Belgium Health Care Knowledge Centre
Leads: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

This content was sourced from clinicaltrials.gov