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| Name | Class |
|---|---|
| Belgium Health Care Knowledge Centre | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator |
| |
| Interventional arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy (CTV=10mm) | Radiation | Radiotherapy with reduced irradiation volume CTV=10mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of days from date of randomization to the date of death due to any cause | From randomization to the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive functioning | Hopkins verbal learning test revised; Trail Marking Test A & B; Controlled Oral Word Association Test | at baseline, 1 month after radiotherapy and at 1 year |
| Radiation-induced toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment until end of follow-up (2 years) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dario Di Perri, MD | Contact | +32 2 764 47 52 | dario.diperri@saintluc.uclouvain.be | |
| Chloë De Laet | Contact | +32 2 764 82 75 | Belgica.kce@saintluc.uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Dario Di Perri, MD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olv Azorg | Not yet recruiting | Aalst | 9300 | Belgium |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2025 | Apr 9, 2025 |
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single blinded, randomized, parallel
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| Radiotherapy (CTV=15mm) | Radiation | Radiotherapy with standard irradiation volume CTV=15mm |
|
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.
| From enrollment until end of follow-up (2 years) |
| Health-related Quality of Life | EQ-5D-5L; QLQ-C30; QLQ-BN20 | From enrollment until end of follow-up (2 years) |
| 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 | From randomization until end of follow-up (2 years) |
| Pattern of recurrence | (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 | From randomization until end of follow-up (2 years) |
| Anti-edema therapy | Recording of the needs of anti-edema therapy | From randomization until end of follow-up (2 years) |
| EpiCURA | Recruiting | Baudour | 7331 | Belgium |
|
| AZ Sint Jan | Recruiting | Bruges | 8000 | Belgium |
|
| Institut Jules Bordet | Not yet recruiting | Brussels | 1070 | Belgium |
|
| UZ Brussel | Not yet recruiting | Brussels | 1090 | Belgium |
|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
|
| Ziekenhuis Oost-Limburg (ZOL) | Recruiting | Genk | 3600 | Belgium |
|
| AZ Sint-Lucas | Recruiting | Ghent | 9000 | Belgium |
|
| UZ Gent | Not yet recruiting | Ghent | 9000 | Belgium |
|
| Grand Hôpital de Charleroi | Recruiting | Gilly | 6060 | Belgium |
|
| JESSA Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
|
| AZ Groeninge | Recruiting | Kortrijk | 8500 | Belgium |
|
| Chu Helora | Recruiting | La Louvière | 7100 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
|
| CHU Liège | Recruiting | Liège | 4000 | Belgium |
|
| AZ Sint Maarten | Recruiting | Mechelen | 2800 | Belgium |
|
| Hôpital André Vésale - HUmani | Recruiting | Montigny-le-Tilleul | 6110 | Belgium |
|
| CH Mouscron | Not yet recruiting | Mouscron | 7700 | Belgium |
|
| CHU UCL Namur - Sainte Elisabeth | Recruiting | Namur | 5000 | Belgium |
|
| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
|
| Cliniques de l'Europe | Recruiting | Uccle | 1180 | Belgium |
|
| CHR Verviers | Recruiting | Verviers | 4800 | Belgium |
|
| ZAS Augustinus | Recruiting | Wilrijk | 2610 | Belgium |
|
| ICF_000.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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