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Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

Study acronym: BELGICA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Site details revised at 15 of 23 sitesv5
  2. Minor Site details revised at 2 of 23 sites
    • Collaborator revised
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 23 of 23 sites
    v3
  4. Minor Study sites: 0 to 23v2 Show 6 more changesShow less
    • Start date: Apr 2025 to May 12, 2025
    • Interventions: Radiotherapy (Radiation) to Radiotherapy (CTV=10mm) (Radiation), Radiotherapy (CTV=15mm) (Radiation)
    • Secondary endpoints: 8 to 6
    • Study description shortened, about 605 words
    • Collaborators expanded, about 6 words
    • Eligibility criteria shortened, about 2 words
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06719440
Lead Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators: Belgium Health Care Knowledge Centre
Conditions
(from sponsor)
Glioblastoma, Radiotherapy Side Effect
Related terms Glioblastoma, Radiation Injuries
Enrollment 347 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov