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Clinical Trials in Germany / NCT02824731
Recruiting Not applicable

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

NCT02824731 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2016-07
Last updated
2024-12-16

Condition(s) studied

Brain Tumors

Investigational drug(s) / intervention(s)

Radiation with protonsRadiation with photons

Study 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

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)

Trial sites (2)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT02824731 on ClinicalTrials.gov ↗ ← All trials in Germany