Clinical trial NCT06719440: Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Radiotherapy Side Effect
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Belgian Health Care Knowledge Centre (KCE)
First posted: 2024-12-05
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blinded, randomized, parallel
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participation in a competing trial
* Known contraindication to undergo MRI scans

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization to the end of the study
Secondary outcomes:
measure: Neurocognitive functioning
timeFrame: at baseline, 1 month after radiotherapy and at 1 year
measure: Radiation-induced toxicity
timeFrame: From enrollment until end of follow-up (2 years)
measure: Health-related Quality of Life
timeFrame: From enrollment until end of follow-up (2 years)
measure: Progression-free survival
timeFrame: From randomization until end of follow-up (2 years)
measure: Pattern of recurrence
timeFrame: From randomization until end of follow-up (2 years)
measure: Anti-edema therapy
timeFrame: From randomization until end of follow-up (2 years)
Other outcomes:
measure: Normal tissue complication probability model (NTCP)
timeFrame: From enrollment until end of follow-up (2 years)
Locations:
city: Aalst
country: Belgium
facility: Olv Azorg
city: Baudour
country: Belgium
facility: EpiCURA
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: UZ Brussel
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL)
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi
city: Hasselt
country: Belgium
facility: JESSA Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: Chu Helora
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU Liège
city: Mechelen
country: Belgium
facility: AZ Sint Maarten
city: Montigny-Le-Tilleul
country: Belgium
facility: Hôpital André Vésale - HUmani
city: Mouscron
country: Belgium
facility: CH Mouscron
city: Namur
country: Belgium
facility: CHU UCL Namur - Sainte Elisabeth
city: Roeselare
country: Belgium
facility: AZ Delta
city: Uccle
country: Belgium
facility: Cliniques de l'Europe
city: Verviers
country: Belgium
facility: CHR Verviers
city: Wilrijk
country: Belgium
facility: ZAS Augustinus
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Dario Di Perri, MD
role: PRINCIPAL_INVESTIGATOR
References: