Comparing proton and photon radiation therapy for glioblastoma
Glioblastoma Radiotherapy Using IMRT or Proton Beams
NA · University Hospital Heidelberg · NCT04752280
This study is testing whether proton beam therapy is better than traditional photon beam therapy for treating glioblastoma by looking at side effects in patients during the first four months of treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 326 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Heidelberg and 2 other locations) |
| Trial ID | NCT04752280 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of proton beam therapy compared to traditional photon beam therapy in patients with glioblastoma. It focuses on assessing the cumulative toxicity experienced by patients during the first four months of treatment. By utilizing proton beams, the study seeks to minimize damage to healthy brain tissue, potentially leading to reduced side effects. Patients will be randomly assigned to receive either photon or proton irradiation as part of their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed glioblastoma who are indicated for radiotherapy.
Not a fit: Patients who have previously received brain radiation or have contraindications to MRI imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective radiation therapy option for glioblastoma patients.
How similar studies have performed: Previous studies have suggested that proton therapy may reduce toxicity compared to photon therapy, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed gliomblastoma WHO IV (operated or after biopsy) * Indication for radiotherapy / radiochemotherapy * Informed consent * KI ≥ 60% or ECOG 0/1 * Age ≥ 18 years * Sufficient effective contraception Exclusion Criteria: * Patient is not able to consent * Previous radiotherapy in the brain or skull base * Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...) * Contraindication to MRI imaging * Simultaneous participation in another clinical trial that could influence the outcome of this study or other study
Where this trial is running
Heidelberg and 2 other locations
- Universitätsklinikum Heidelberg — Heidelberg, Germany (RECRUITING)
- Universitätsklinikum Gießen und Marburg — Marburg, Germany (NOT_YET_RECRUITING)
- Klinikum Stuttgart — Stuttgart, Germany (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Klaus Herfarth, Prof. Dr.
- Email: studienkoordination.RAD@med.uni-heidelberg.de
- Phone: +49 6221 56 34093
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: Glioblastoma