Comparing proton and photon radiotherapy for brain tumors
Comparison of Proton and Photon Radiotherapy of Brain Tumors: Efficiency and Side Effects in Clinical Standard Doses
This study tests whether proton therapy causes less long-term side effects than photon therapy in patients with different types of brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 555 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Dresden and 1 other locations) |
| Trial ID | NCT02824731 on ClinicalTrials.gov |
What this trial studies
This protocol compares the toxicity of proton and photon radiotherapy in patients with various types of brain tumors requiring high-dose treatment. It is a non-randomized, two-arm trial where patients choose their treatment based on availability. The study stratifies patients into four groups based on tumor type and prior treatment history, applying standard doses of radiotherapy. The primary focus is on assessing chronic toxicity and quality of life one year after treatment, with the hypothesis that proton therapy will result in 15% lower chronic toxicity compared to photon therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with primary brain tumors or recurrences that are eligible for high-dose radiotherapy.
Not a fit: Patients with cerebral lymphomas, brain metastases, or very small tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options with reduced long-term side effects for patients with brain tumors.
How similar studies have performed: Other studies have shown promising results with proton therapy, suggesting potential benefits over traditional photon therapy, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * primary brain tumor: gliomas (low or high grade), intracerebral meningiomas, pituitary adenomas, craniopharyngioma and other rare brain tumors or * brain tumor recurrence without pre-irradiation or * brain tumor recurrence with pre-irradiation \> 40 Gy in the overlap region with the recurrence region * indication for radiotherapy or radiochemotherapy * Both proton and photon therapy are possible from a medical point of view (that is no standard indication for protons or standard indication for example one-time stereotaxy * age \>= 18 years * general condition ECOG ≤ 2, outpatient basis possible * indication for high dose (except group 4) radiotherapy or radiochemotherapy * capacity to consent and present written informed consent Exclusion Criteria: * lack of capacity to consent or lack of written consent * cerebral lymphomas * brain metastases * very small tumors (for example acoustic neuromas, very small recurrences) for this is a proton therapy from a medical point of view no alternative to a stereotactic radiotherapy * inability to MRI planning (eg. contraindications to performing MRI) * lack of compliance of the patient * lack of or limited possibility of a reproducible storage (eg by severe restriction of mobility of the patient) * missing or limited possibility of regular follow-up visits in accordance with the study protocol
Where this trial is running
Dresden and 1 other locations
- University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology — Dresden, Germany (Recruiting)
- University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology — Marburg, Germany (Recruiting)
Study contacts
- Study coordinator: Mechthild Krause, Prof.
- Email: mechthild.krause@uniklinikum-dresden.de
- Phone: +49 351 458 5441
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.