Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume
BELGICA
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
1 other identifier
interventional
347
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
February 27, 2026
August 1, 2025
6.4 years
November 15, 2024
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Number of days from date of randomization to the date of death due to any cause
From randomization to the end of the study
Secondary Outcomes (6)
Neurocognitive functioning
at baseline, 1 month after radiotherapy and at 1 year
Radiation-induced toxicity
From enrollment until end of follow-up (2 years)
Health-related Quality of Life
From enrollment until end of follow-up (2 years)
Progression-free survival
From randomization until end of follow-up (2 years)
Pattern of recurrence
From randomization until end of follow-up (2 years)
- +1 more secondary outcomes
Other Outcomes (1)
Normal tissue complication probability model (NTCP)
From enrollment until end of follow-up (2 years)
Study Arms (2)
Standard of Care
ACTIVE COMPARATORInterventional arm
EXPERIMENTALInterventions
Radiotherapy with reduced irradiation volume CTV=10mm
Radiotherapy with standard irradiation volume CTV=15mm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participation in a competing trial
- Known contraindication to undergo MRI scans
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Olv Azorg
Aalst, 9300, Belgium
EpiCURA
Baudour, 7331, Belgium
AZ Sint Jan
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk, 3600, Belgium
AZ Sint-Lucas
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
Grand Hôpital de Charleroi
Gilly, 6060, Belgium
JESSA Ziekenhuis
Hasselt, 3500, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Chu Helora
La Louvière, 7100, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU Liège
Liège, 4000, Belgium
AZ Sint Maarten
Mechelen, 2800, Belgium
Hôpital André Vésale - HUmani
Montigny-le-Tilleul, 6110, Belgium
CH Mouscron
Mouscron, 7700, Belgium
CHU UCL Namur - Sainte Elisabeth
Namur, 5000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Cliniques de l'Europe
Uccle, 1180, Belgium
CHR Verviers
Verviers, 4800, Belgium
ZAS Augustinus
Wilrijk, 2610, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dario Di Perri, MD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2024
First Posted
December 5, 2024
Study Start
May 12, 2025
Primary Completion (Estimated)
October 1, 2031
Study Completion (Estimated)
October 1, 2031
Last Updated
February 27, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share