Comparing proton and photon radiotherapy for brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.