RecruitingNot ApplicableNCT02824731

Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)

Comparison of Proton and Photon Radiotherapy of Brain Tumors: Efficiency and Side Effects in Clinical Standard Doses

Sponsor

Technische Universität Dresden

Enrollment

555 participants

Start Date

Jul 1, 2016

Study Type

INTERVENTIONAL

Conditions

Brain Tumors

Summary

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria8

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