This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with different radiation modalities - protons or photons. Patients with different kinds of brain tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
late toxicity as cumulative measure — 1 year (or at least 6 months) Events for the endpoint are:
1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions)
2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by \>10%
3. decrease in brain function (MOCA test) by more than 10%
Trial sites (2)
Facility
City
Region
Status
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
More Technische Universität Dresden trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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