GlioblastomaBELGICANCT06719440
Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume
A study testing Radiotherapy (CTV=10mm) and Radiotherapy (CTV=15mm) in people with Glioblastoma and Radiotherapy Side Effect, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 23 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Radiotherapy Side Effect
- What is being tested?
- Radiotherapy (CTV=10mm) and Radiotherapy (CTV=15mm)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 23 sitesBelgium
- Study dates
- 12 May 2025to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in a competing trial
- Known contraindication to undergo MRI scans
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
Belgium23 sites, 23 recruiting
- Not yet recruiting
Olv Azorg
Aalst, 9300
Secretary office, +32 53 72 86 66, radiotherapie@azorg.be
Samuel Bral, MD
- Recruiting
EpiCURA
Baudour, 7331
Secretary office, +32 65 61 44 86
Serge Ndam, MD
- Recruiting
AZ Sint Jan
Bruges, 8000
Secretary office, +32 50 45 28 00, radiotherapie.brugge@azsintjan.be
Martijn Swimberghe, MD
- Not yet recruiting
Institut Jules Bordet
Brussels, 1070
Secretary office, +32 2 541 38 00, accueil.cons.radiotherapie@hubruxelles.be
Philippe Martinive, MD
- Not yet recruiting
UZ Brussel
Brussels, 1090
Secretary office, +32 2 477 60 41, balie-radiotherapie@uzbrussel.be
Selma Ben Mustapha, MD
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Secretary office, +32 2 764 47 52
Dario Di Perri, MD
- Recruiting
Ziekenhuis Oost-Limburg (ZOL)
Genk, 3600
Secretary office, +32 89 80 83 30
Mieke Govers, MD
- Recruiting
AZ Sint-Lucas
Ghent, 9000
Secretary office, +32 9 224 66 20, secretariaat.radonco@azstlucas.be
Wim Duthoy
- Not yet recruiting
UZ Gent
Ghent, 9000
Secretary office, +32 9 332 30 15, secretariaat.radiotherapie@uzgent.be
Tom Boterberg, MD
- Recruiting
Grand Hôpital de Charleroi
Gilly, 6060
Secretary office, +32 60 11 12 13
Benjamin Ledoux, MD
- Recruiting
JESSA Ziekenhuis
Hasselt, 3500
Secretary office, +32 11 33 79 79
Anne-Sophe Van de Velde, MD
- Recruiting
AZ Groeninge
Kortrijk, 8500
Secretary office, +32 56 63 39 03, radiotherapie@azgroeninge.be
Nick Liefhooghe, MD
- Recruiting
Chu Helora
La Louvière, 7100
Secretary office, +32 64 23 41 88
Samuel Palumbo, MD
- Recruiting
UZ Leuven
Leuven, 3000
Secretary office, +32 16 34 76 00
Maarten Lambrecht, MD
- Recruiting
CHU Liège
Liège, 4000
Secretary office, +32 4 323 75 96, radiotherapie@chuliege.be
Lisa Grandjean, MD
- Recruiting
AZ Sint Maarten
Mechelen, 2800
Secretary office, +32 15 89 29 80
Julie Van der Veen, MD
- Recruiting
Hôpital André Vésale - HUmani
Montigny-le-Tilleul, 6110
Secretary Office, +32 71 92 09 52
Martin Manderlier, MD
- Not yet recruiting
CH Mouscron
Mouscron, 7700
Secretary office, +32 56 85 83 60, secretariat.radiotherapie@chmouscron.be
Katrien Thevissen, MD
- Recruiting
CHU UCL Namur - Sainte Elisabeth
Namur, 5000
Secretary office, +32 81 72 05 25
Marie Wanet, MD
- Recruiting
AZ Delta
Roeselare, 8800
Secretary office, +32 51 23 75 82
Caroline Sweldens, MD
- Recruiting
Cliniques de l'Europe
Uccle, 1180
Secretary office (Sainte Elisabeth), +32 2 614 25 40
Secretary office (Saint Michel), +32 2 614 37 26
- Recruiting
CHR Verviers
Verviers, 4800
Secretary office, +32 87 21 24 22
David Devillers, MD
- Recruiting
ZAS Augustinus
Wilrijk, 2610
Secretary office, +32 3 443 37 37, secretariaat@iridiumnetwerk.be
Carole Mercier, MD
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Glioblastoma, Radiotherapy Side Effect
- Being tested
- Radiotherapy (CTV=10mm), Radiotherapy (CTV=15mm)
- Medical subject headings
- Glioblastoma, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy (CTV=10mm)Radiation
Radiotherapy with reduced irradiation volume CTV=10mm
Radiotherapy (CTV=15mm)Radiation
Radiotherapy with standard irradiation volume CTV=15mm
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Radiation: Radiotherapy (CTV=15mm) |
| Interventional arm | Experimental | Not described Receives: Radiation: Radiotherapy (CTV=10mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Number of days from date of randomization to the date of death due to any cause
Measured: From randomization to the end of the study
Secondary outcomes (6)
Neurocognitive functioning
Hopkins verbal learning test revised; Trail Marking Test A \& B; Controlled Oral Word Association Test
Measured: at baseline, 1 month after radiotherapy and at 1 year
Radiation-induced toxicity
Assessment of fatigue, headache, nausea, alopecia and radiatio dermatitis according to the CTCAE assessment score. Score ranges from Grade 1 to Grade 5, with higher grades resulting in more severe symptoms.
Measured: From enrollment until end of follow-up (2 years)
Health-related Quality of Life
EQ-5D-5L; QLQ-C30; QLQ-BN20
Measured: From enrollment until end of follow-up (2 years)
Progression-free survival
Length of time during and after treatment for a disease, such as cancer, that a patient lives with the disease without it worsening
Measured: From randomization until end of follow-up (2 years)
Pattern of recurrence
(in case of progression) Manner in which the tumor returns after a period of improvement or remission. It often involves tracking the frequency, timing, and location of the tumor's return
Measured: From randomization until end of follow-up (2 years)
Anti-edema therapy
Recording of the needs of anti-edema therapy
Measured: From randomization until end of follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start12 May 2025
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blinded, randomized, parallel
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre
- Responsible party
- Sponsor
- Investigators
- Dario Di Perri, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719440
- Sponsor's protocol ID
- KCE23-1426
- Acronym
- BELGICA
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06719440
- Acronym / sponsor ID
- BELGICA / KCE23-1426
- Conditions
- Glioblastoma, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 347 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre
- Study start
- 12 May 2025 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blinded, randomized, parallel
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Radiation: Radiotherapy (CTV=15mm) |
| Interventional arm | Experimental | Radiation: Radiotherapy (CTV=10mm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in a competing trial
- Known contraindication to undergo MRI scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy (CTV=10mm)Radiotherapy with reduced irradiation volume CTV=10mm | Radiation | Interventional arm |
| Radiotherapy (CTV=15mm)Radiotherapy with standard irradiation volume CTV=15mm | Radiation | Standard of Care |
Primary outcome
Overall Survival
Time frame: From randomization to the end of the study
Number of days from date of randomization to the date of death due to any cause
6 secondary outcomes
Neurocognitive functioning
Time frame: at baseline, 1 month after radiotherapy and at 1 year
Radiation-induced toxicity
Time frame: From enrollment until end of follow-up (2 years)
Health-related Quality of Life
Time frame: From enrollment until end of follow-up (2 years)
Progression-free survival
Time frame: From randomization until end of follow-up (2 years)
Pattern of recurrence
Time frame: From randomization until end of follow-up (2 years)
Anti-edema therapy
Time frame: From randomization until end of follow-up (2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dario Di Perri, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy (CTV=10mm) and Radiotherapy (CTV=15mm) in people with Glioblastoma and Radiotherapy Side Effect, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 23 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dario Di Perri, MD (+32 2 764 47 52, dario.diperri@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From randomization to the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.