Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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 )

Disqualifiers

Participation in a competing trial

Known contraindication to undergo MRI scans

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy (CTV=10mm)

    Radiation

    Radiotherapy with reduced irradiation volume CTV=10mm

  • Radiotherapy (CTV=15mm)

    Radiation

    Radiotherapy with standard irradiation volume CTV=15mm

Treatment groups

347 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: Interventional armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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)
3

Health-related Quality of Life

EQ-5D-5L; QLQ-C30; QLQ-BN20

Time frame
From enrollment until end of follow-up (2 years)
4

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)

Other outcomes

1

Normal tissue complication probability model (NTCP)

To develop a normal tissue complication probability model (NTCP) for radiation-induced cognitive toxicity, based on clinical and dosimetric measures (e.g. radiation dose delivered to brain structures)

Time frame
From enrollment until end of follow-up (2 years)

Sponsors and contacts

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