Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06719440
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dario Di Perri, MD
Principal Investigator Affiliation Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Radiotherapy Side Effect
Arms & Interventions

Arms

Active Comparator: Standard of Care

Experimental: Interventional arm

Interventions

Radiation: - Radiotherapy (CTV=10mm)

Radiotherapy with reduced irradiation volume CTV=10mm

Radiation: - Radiotherapy (CTV=15mm)

Radiotherapy with standard irradiation volume CTV=15mm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Olv Azorg, Aalst, Belgium

Status

Address

Olv Azorg

Aalst, , 9300

Site Contact

Secretary office

[email protected]

+32 53 72 86 66

EpiCURA, Baudour, Belgium

Status

Address

EpiCURA

Baudour, , 7331

Site Contact

Secretary office

[email protected]

+32 65 61 44 86

AZ Sint Jan, Brugge, Belgium

Status

Address

AZ Sint Jan

Brugge, , 8000

Site Contact

Secretary office

[email protected]

+32 50 45 28 00

Cliniques universitaires Saint-Luc, Brussels, Belgium

Status

Address

Cliniques universitaires Saint-Luc

Brussels, , 1200

Site Contact

Secretary office

[email protected]

+32 2 764 47 52

Institut Jules Bordet, Bruxelles, Belgium

Status

Address

Institut Jules Bordet

Bruxelles, , 1070

Site Contact

Secretary office

[email protected]

+32 2 541 38 00

UZ Brussel, Bruxelles, Belgium

Status

Address

UZ Brussel

Bruxelles, , 1090

Site Contact

Secretary office

[email protected]

+32 2 477 60 41

Ziekenhuis Oost-Limburg (ZOL), Genk, Belgium

Status

Address

Ziekenhuis Oost-Limburg (ZOL)

Genk, , 3600

Site Contact

Secretary office

[email protected]

+32 89 80 83 30

AZ Sint-Lucas, Gent, Belgium

Status

Address

AZ Sint-Lucas

Gent, , 9000

Site Contact

Secretary office

[email protected]

+32 9 224 66 20

UZ Gent, Gent, Belgium

Status

Address

UZ Gent

Gent, , 9000

Site Contact

Secretary office

[email protected]

+32 9 332 30 15

Grand Hôpital de Charleroi, Gilly, Belgium

Status

Address

Grand Hôpital de Charleroi

Gilly, , 6060

Site Contact

Secretary office

[email protected]

+32 60 11 12 13

JESSA Ziekenhuis, Hasselt, Belgium

Status

Address

JESSA Ziekenhuis

Hasselt, , 3500

Site Contact

Secretary office

[email protected]

+32 11 33 79 79

AZ Groeninge, Kortrijk, Belgium

Status

Address

AZ Groeninge

Kortrijk, , 8500

Site Contact

Secretary office

[email protected]

+32 56 63 39 03

Chu Helora, La Louvière, Belgium

Status

Address

Chu Helora

La Louvière, , 7100

Site Contact

Secretary office

[email protected]

+32 64 23 41 88

UZ Leuven, Leuven, Belgium

Status

Address

UZ Leuven

Leuven, , 3000

Site Contact

Secretary office

[email protected]

+32 16 34 76 00

CHU Liège, Liège, Belgium

Status

Address

CHU Liège

Liège, , 4000

Site Contact

Secretary office

[email protected]

+32 4 323 75 96

AZ Sint Maarten, Mechelen, Belgium

Status

Address

AZ Sint Maarten

Mechelen, , 2800

Site Contact

Secretary office

[email protected]

+32 15 89 29 80

Hôpital André Vésale - HUmani, Montigny-Le-Tilleul, Belgium

Status

Address

Hôpital André Vésale - HUmani

Montigny-Le-Tilleul, , 6110

Site Contact

Secretary Office

[email protected]

+32 71 92 09 52

CH Mouscron, Mouscron, Belgium

Status

Address

CH Mouscron

Mouscron, , 7700

Site Contact

Secretary office

[email protected]

+32 56 85 83 60

CHU UCL Namur - Sainte Elisabeth, Namur, Belgium

Status

Address

CHU UCL Namur - Sainte Elisabeth

Namur, , 5000

Site Contact

Secretary office

[email protected]

+32 81 72 05 25

AZ Delta, Roeselare, Belgium

Status

Address

AZ Delta

Roeselare, , 8800

Site Contact

Secretary office

[email protected]

+32 51 23 75 82

Cliniques de l'Europe, Uccle, Belgium

Status

Address

Cliniques de l'Europe

Uccle, , 1180

Site Contact

Secretary office (Sainte Elisabeth)

[email protected]

+32 2 614 25 40

CHR Verviers, Verviers, Belgium

Status

Address

CHR Verviers

Verviers, , 4800

Site Contact

Secretary office

[email protected]

+32 87 21 24 22

ZAS Augustinus, Wilrijk, Belgium

Status

Address

ZAS Augustinus

Wilrijk, , 2610

Site Contact

Secretary office

[email protected]

+32 3 443 37 37

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