Radiotherapy (CTV=10mm)
RadiationRadiotherapy with reduced irradiation volume CTV=10mm
NCT Number: NCT06719440
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Olv Azorg, Aalst, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiotherapy with reduced irradiation volume CTV=10mm
Radiotherapy with standard irradiation volume CTV=15mm
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
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
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.
Time frame: From enrollment until end of follow-up (2 years)
EQ-5D-5L; QLQ-C30; QLQ-BN20
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
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
Time frame: From randomization until end of follow-up (2 years)
Recording of the needs of anti-edema therapy
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)
Contact information is provided by the study sponsor or research team.
Chloë De Laet
CONTACT
Dario Di Perri, MD
CONTACT
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Other
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
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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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