Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2031-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma Radiotherapy Side Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single blinded, randomized, parallel

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care

Group Type ACTIVE_COMPARATOR

Radiotherapy (CTV=15mm)

Intervention Type RADIATION

Radiotherapy with standard irradiation volume CTV=15mm

Interventional arm

Group Type EXPERIMENTAL

Radiotherapy (CTV=10mm)

Intervention Type RADIATION

Radiotherapy with reduced irradiation volume CTV=10mm

Interventions

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Radiotherapy (CTV=10mm)

Radiotherapy with reduced irradiation volume CTV=10mm

Intervention Type RADIATION

Radiotherapy (CTV=15mm)

Radiotherapy with standard irradiation volume CTV=15mm

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dario Di Perri, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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