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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
347
Radiotherapy with reduced irradiation volume CTV=10mm
Radiotherapy with standard irradiation volume CTV=15mm
Olv Azorg
Aalst, Belgium
NOT_YET_RECRUITINGEpiCURA
Baudour, Belgium
RECRUITINGAZ Sint Jan
Bruges, Belgium
RECRUITINGInstitut Jules Bordet
Brussels, Belgium
NOT_YET_RECRUITINGUZ Brussel
Brussels, Belgium
NOT_YET_RECRUITINGCliniques universitaires Saint-Luc
Brussels, Belgium
RECRUITINGZiekenhuis Oost-Limburg (ZOL)
Genk, Belgium
RECRUITINGAZ Sint-Lucas
Ghent, Belgium
RECRUITINGUZ Gent
Ghent, Belgium
NOT_YET_RECRUITINGGrand Hôpital de Charleroi
Gilly, Belgium
RECRUITING...and 13 more locations
Overall Survival
Number of days from date of randomization to the date of death due to any cause
Time frame: From randomization to the end of the study
Neurocognitive functioning
Hopkins verbal learning test revised; Trail Marking Test A \& B; Controlled Oral Word Association Test
Time frame: 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.
Time frame: From enrollment until end of follow-up (2 years)
Health-related Quality of Life
EQ-5D-5L; QLQ-C30; QLQ-BN20
Time frame: 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
Time frame: 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
Time frame: From randomization until end of follow-up (2 years)
Anti-edema therapy
Recording of the needs of anti-edema therapy
Time frame: From randomization until end of follow-up (2 years)
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