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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. What is glioblastoma (GBM)? GBM is the most common and aggressive tumour originating from the brain, affecting approximately 600 patients per year in Belgium. What is the current treatment for patients with GBM? The treatment consists in surgical resection of the tumour (when feasible), followed by a combination of radiotherapy and chemotherapy. What is the outcome of patients with GBM? 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. How is radiotherapy applied in GBM, and how could this be improved to decrease side effects and improve quality of life? 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. What is the BELGICA trial? 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.

- 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
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Radiotherapy Side Effect

Additional Details

INDICATION : Patients with newly diagnosed glioblastoma for whom radiochemotherapy is indicated.RATIONALE : Glioblastoma is the most frequent primary malignant brain tumour, annually affecting approximately 600 patients in Belgium. The current management of glioblastoma includes surgical resection (when feasible), followed by radiotherapy (RT) and chemotherapy. Despite this multimodal treatment, the prognosis of patients with glioblastoma is dismal with a median overall survival of approximately 1 year. In addition to poor survival, patients with glioblastoma face several symptoms, notably cognitive decline and deterioration in quality of life (QOL), which are both resulting from the disease evolution and the treatments. Given the limited life expectancy of these patients, improvement of well-being during the remaining survival period is essential and is a major concern for glioblastoma patients and their relatives. In glioblastoma, radiotherapy is targeted at the tumour (or tumour bed after resection) with a safety margin around it (i.e., the "Clinical Target Volume" or CTV) to account for potential microscopic extension of the tumour. The downside of this safety margin is that a substantial amount of normal 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. Current European guidelines in glioblastoma recommend a clinical target volume (CTV) margin of 15 mm around the tumour. However, the optimal target volume is still unknown, mainly based on historical practices, and different margins have been used in clinical practice. The BELGICA trial will prospectively evaluate if reducing the CTV margin from 15 to 10 mm allows for improving the toxicity profile of the treatment without compromising the outcome. This intervention is expected to be safe and to reduce toxicity based on available clinical data. Target volume reduction in glioblastoma Several retrospective or prospective non-randomized series of patients treated with a <= 10 mm CTV margin showed local control and survival outcomes similar to those of patients treated with larger margins, which supports the safety of the intervention. Similarly, pattern of recurrence analysis in patients treated with a >= 15 mm CTV suggests that using a 10 mm CTV margin would not lead to more recurrences. Relation between radiation dose and toxicity in glioblastoma Current clinical data in patients with glioblastoma show that lower radiation dose to surrounding normal brain structures is associated with lower cognitive decline, improved QOL, reduced toxicity and fatigue. Glioblastoma, radiotherapy, and cognitive decline Most patients with glioblastoma present with neurocognitive dysfunction at the time of diagnosis and will experience further progressive decline during the clinical course of the disease. This occurs early, with a median time to deterioration of approximately 1 months . Neurocognitive decline is multifactorial, due to tumour-, patient-, and treatment-related factors. Cranial irradiation is associated with cognitive toxicity. In patients with brain metastases, strategies aiming to reduce the radiation dose to the surrounding brain structures have allowed to reduce the rate of cognitive decline, e.g. hippocampal-avoidance in patients receiving whole-brain radiotherapy. By reducing the irradiation volume in patients with glioblastoma, the dose to the surrounding brain structures will be lowered, potentially reducing the rate of cognitive decline. METHODS : The BELGICA trial will include 347 patients in Belgium with newly diagnosed glioblastoma. The patients will be randomized 1:1 into two groups. The experimental group will receive a radiotherapy with a reduced irradiation volume (CTV 10mm). The control group will receive radiotherapy with standard irradiation volume (CTV 15mm). In both groups, patients will receive temozolomide chemotherapy in association with radiotherapy. Stratification factors are: age (under/above 70 years), MGMT promotor methylation status (methylated/unmethylated/unknown), and extent of resection.

Arms & Interventions

Arms

Active Comparator: Radiotherapy with standard irradiation volume

Radiotherapy with standard irradiation volume CTV=15mm

Experimental: Radiotherapy with reduced irradiation volume

Radiotherapy with standard irradiation volume CTV=10mm

Interventions

Radiation: - Radiotherapy

Radiotherapy as SoC for glioblastoma

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Dario Di Perri, MD

[email protected]

+32 2 7648190

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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