Glioblastoma, Radiotherapy Side Effect
Conditions
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.
Interventions
RADIATIONRadiotherapy (CTV=10mm)
Radiotherapy with reduced irradiation volume CTV=10mm
RADIATIONRadiotherapy (CTV=15mm)
Radiotherapy with standard irradiation volume CTV=15mm
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Belgium Health Care Knowledge Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
single blinded, randomized, parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From randomization to the end of the study | Number of days from date of randomization to the date of death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive functioning | at baseline, 1 month after radiotherapy and at 1 year | Hopkins verbal learning test revised; Trail Marking Test A \& B; Controlled Oral Word Association Test |
| Radiation-induced toxicity | From enrollment until end of follow-up (2 years) | 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. |
| Health-related Quality of Life | From enrollment until end of follow-up (2 years) | EQ-5D-5L; QLQ-C30; QLQ-BN20 |
| Progression-free survival | From randomization until end of follow-up (2 years) | Length of time during and after treatment for a disease, such as cancer, that a patient lives with the disease without it worsening |
| Pattern of recurrence | From randomization until end of follow-up (2 years) | (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 |
| Anti-edema therapy | From randomization until end of follow-up (2 years) | Recording of the needs of anti-edema therapy |
Countries
Belgium
Contacts
CONTACTDario Di Perri, MD
CONTACTChloë De Laet
PRINCIPAL_INVESTIGATORDario Di Perri, MD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Outcome results
None listed