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

Recruiting now · Not applicable

Conditions studied: Brain Tumors

In brief

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.

Key facts

Study ID

NCT02824731

Run by

Technische Universität Dresden

People needed

555

Starts

2016-07-01

Expected to finish

2029-10-01

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology — Dresden, Germany (enrolling)
• University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology — Marburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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