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NCT Number: NCT06719440

Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olv Azorg, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy (CTV=10mm)

Radiation

Radiotherapy with reduced irradiation volume CTV=10mm

Radiotherapy (CTV=15mm)

Radiation

Radiotherapy with standard irradiation volume CTV=15mm

Primary outcomes

  1. Overall Survival

    Time frame: 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 outcomes

  1. Neurocognitive functioning

    Time frame: 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

  2. Radiation-induced toxicity

    Time frame: 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.

  3. Health-related Quality of Life

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

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

  4. Progression-free survival

    Time frame: 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

  5. Pattern of recurrence

    Time frame: 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

  6. Anti-edema therapy

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

    Recording of the needs of anti-edema therapy

Other outcomes

  1. Normal tissue complication probability model (NTCP)

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chloë De Laet

CONTACT

[email protected]

+32 2 764 82 75

Dario Di Perri, MD

CONTACT

[email protected]

+32 2 764 47 52

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Collaborators

  • Belgium Health Care Knowledge Centre

Registry information

Official study 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

Acronym: BELGICA

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Dec 5, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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