Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy (CTV=10mm), Radiotherapy (CTV=15mm).
- Who it may be relevant to
- Registry conditions: Glioblastoma, Radiotherapy Side Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Radiation Radiotherapy (CTV=10mm)
Radiotherapy with reduced irradiation volume CTV=10mm - Radiation Radiotherapy (CTV=15mm)
Radiotherapy with standard irradiation volume CTV=15mm
Primary outcome measures
- Overall Survival [Time frame: From randomization to the end of the study]
Secondary outcome measures (6)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 23 centers
- Olv Azorg — Aalst
- EpiCURA — Baudour
- AZ Sint Jan — Bruges
- Institut Jules Bordet — Brussels
- UZ Brussel — Brussels
- Cliniques universitaires Saint-Luc — Brussels
- Ziekenhuis Oost-Limburg (ZOL) — Genk
- AZ Sint-Lucas — Ghent
- … and 15 more centers
Identifiers
NCT: NCT06719440 · KCE23-1426