Limiting the radiation target area for glioblastoma to reduce treatment side effects
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
This trial will test whether giving radiotherapy with a smaller margin around the tumor (10 mm instead of 15 mm) for adults with newly diagnosed glioblastoma can reduce side effects and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 347 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 23 sites (Aalst and 22 other locations) |
| Trial ID | NCT06719440 on ClinicalTrials.gov |
What this trial studies
The trial compares two radiotherapy approaches that differ in the clinical target volume margin (10 mm versus 15 mm) delivered with standard concurrent and adjuvant chemotherapy. Adults with newly diagnosed, histologically confirmed glioblastoma and WHO performance status 0–2 are enrolled after multidisciplinary board confirmation. Participants receive one of the two radiotherapy plans and are followed with regular MRI and clinical assessments to record treatment-related toxicity, cognitive effects, quality of life, and tumor control. The goal is to see whether a tighter radiation margin can lower radiation-related side effects without compromising disease control.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed, histologically confirmed glioblastoma who are planned for standard chemoradiotherapy and have WHO performance status 0–2 are the intended participants.
Not a fit: Patients with recurrent disease, those unable to undergo MRI, those in competing trials, or those not eligible for standard chemoradiotherapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lessen radiation-related brain injury and improve patients' quality of life while keeping cancer control similar.
How similar studies have performed: Similar attempts to reduce radiotherapy margins in glioblastoma have been explored before with mixed results, so this approach is still investigational.
Eligibility criteria
Show full 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
Where this trial is running
Aalst and 22 other locations
- Olv Azorg — Aalst, Belgium (Not_yet_recruiting)
- EpiCURA — Baudour, Belgium (Recruiting)
- AZ Sint Jan — Bruges, Belgium (Recruiting)
- Institut Jules Bordet — Brussels, Belgium (Not_yet_recruiting)
- UZ Brussel — Brussels, Belgium (Not_yet_recruiting)
- Cliniques universitaires Saint-Luc — Brussels, Belgium (Recruiting)
- Ziekenhuis Oost-Limburg (ZOL) — Genk, Belgium (Recruiting)
- AZ Sint-Lucas — Ghent, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- Grand Hôpital de Charleroi — Gilly, Belgium (Recruiting)
- JESSA Ziekenhuis — Hasselt, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
- Chu Helora — La Louvière, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU Liège — Liège, Belgium (Recruiting)
- AZ Sint Maarten — Mechelen, Belgium (Recruiting)
- Hôpital André Vésale - HUmani — Montigny-le-Tilleul, Belgium (Recruiting)
- CH Mouscron — Mouscron, Belgium (Not_yet_recruiting)
- CHU UCL Namur - Sainte Elisabeth — Namur, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Cliniques de l'Europe — Uccle, Belgium (Recruiting)
- CHR Verviers — Verviers, Belgium (Recruiting)
- ZAS Augustinus — Wilrijk, Belgium (Recruiting)
Study contacts
- Principal investigator: Dario Di Perri, MD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Dario Di Perri, MD
- Email: dario.diperri@saintluc.uclouvain.be
- Phone: +32 2 764 47 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.