Outcomes of Proton vs. Photon Therapy for IDH Mutated Gliomas
Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas
This study tests whether proton therapy works better and is safer than photon therapy for people with certain types of brain tumors called IDH mutated gliomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06180434 on ClinicalTrials.gov |
What this trial studies
This study investigates the short-term outcomes of patients with grade 2 and 3 IDH mutated gliomas treated with proton therapy compared to those treated with photon therapy. It involves a retrospective analysis of data collected from multiple medical centers in the Netherlands, focusing on interventions, survival rates, and toxicity following treatment. The aim is to determine if proton therapy offers any advantages in terms of disease progression and safety compared to traditional photon therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed grade 2 or 3 IDH mutated gliomas who received radiotherapy between January 1, 2018, and June 30, 2022.
Not a fit: Patients who have received prior cranial radiotherapy or those who have contraindications for MRI imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and safety of proton therapy, potentially leading to improved treatment options for glioma patients.
How similar studies have performed: While this study explores a relatively novel approach, previous studies have indicated potential benefits of proton therapy in reducing radiation exposure to healthy tissue, though direct comparisons with photon therapy in this specific context are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathologically confirmed WHO grade 2 or grade WHO 3 IDHmt glioma * Treatment with radiotherapy delivered between 1 of January 2018 and completed before or on the 30th of June 2022 * Treatment with chemotherapy delivered after radiotherapy (PCV or Temozolomide) * Age ≥ 18 years Exclusion Criteria: * Prior cranial radiotherapy * Contra-indication for MRI imaging * Chemotherapy delivered before radiotherapy * Dose and fractionation other that standard dose (50.4 Gy in 28 fractions for Grade 2 and 59.5 Gy in 33 fractions for Grade 3) * Combination photon and proton therapy * Patient has previously opted-out of the use of their data for research
Where this trial is running
Rotterdam
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Alejandra Mendez Romero, MD PhD — Assitant Professor, Radiation Oncologist
- Study coordinator: Steven HJ Nagtegaal, MD PhD
- Email: s.nagtegaal@erasmusmc.nl
- Phone: +31(0)107042249
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.