Proton therapy for brain tumors
Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
Maastricht Radiation Oncology · NCT04648462
This study is testing whether proton therapy can be a better treatment option for patients with certain brain tumors by comparing it to traditional radiation methods to see if it can reduce harm to healthy tissues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht Radiation Oncology (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Maastricht, Limburg and 2 other locations) |
| Trial ID | NCT04648462 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the application of proton therapy for patients with specific brain tumors, including astrocytoma and oligodendroglioma. It utilizes a model-based approach to compare proton and photon treatment plans for individual patients, assessing the potential reduction in radiation dose to healthy tissues and the expected clinical benefits. The study aims to identify patients who would benefit most from proton therapy by analyzing dosimetric gains and normal tissue complication probabilities. The research is conducted across multiple leading medical centers in the Netherlands.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with brain tumors that have a favorable prognosis and minimal neurocognitive impairment.
Not a fit: Patients who are not eligible for chemotherapy or are suitable for stereotactic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced radiation-induced complications and improved outcomes for patients with brain tumors.
How similar studies have performed: Other studies have shown promise in using proton therapy for similar conditions, indicating a growing body of evidence supporting this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All brain tumors with a favorable prognosis (median survival \> 10 year) 2. Age ≥ 18 years 3. ECOG performance status 0 - 1 / Karnofsky performance status 80 - 100 4. No - minimal neurocognitive impairment 5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi) 6. Informed consent Exclusion Criteria: 1. Not eligible for chemotherapy 2. Eligible for stereotactic radiotherapy
Where this trial is running
Maastricht, Limburg and 2 other locations
- Maastricht Radiation Oncology — Maastricht, Limburg, Netherlands (RECRUITING)
- Holland PTC — Delft, South Holland, Netherlands (RECRUITING)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Danielle Eekers — Maastro Clinic, The Netherlands
- Study coordinator: Danielle Eekers
- Email: danielle.eekers@maastro.nl
- Phone: +31884455600
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.
Conditions: Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma, Nerve Sheath Neoplasms, Adenoma