NCT02824731 Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)
| NCT ID | NCT02824731 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technische Universität Dresden |
| Condition | Brain Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 555 participants |
| Start Date | 2016-07 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 555 participants in total. It began in 2016-07 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Mechthild Krause, Prof.
STUDY CHAIR
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Frequently Asked Questions
Who can join the NCT02824731 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02824731 currently recruiting?
Yes, NCT02824731 is actively recruiting participants. Contact the research team at mechthild.krause@uniklinikum-dresden.de for enrollment information.
Where is the NCT02824731 trial being conducted?
This trial is being conducted at Dresden, Germany, Marburg, Germany.
Who is sponsoring the NCT02824731 clinical trial?
NCT02824731 is sponsored by Technische Universität Dresden. The principal investigator is Mechthild Krause, Prof. at University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK). The trial plans to enroll 555 participants.