Clinical trial · Interventional
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
NCT02824731CI-TRIAL-00083751recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation with photons | Radiation | — | UNRESOLVED |
| Radiation with protons | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- ACTIVE_COMPARATOR
- label
- supratentorial, grade III/IV, photon
- description
- Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
- interventionNames
- Radiation: Radiation with photons
- type
- EXPERIMENTAL
- label
- supratentorial, grade III/IV, proton
- description
- Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
- interventionNames
- Radiation: Radiation with protons
- type
- ACTIVE_COMPARATOR
- label
- supratentorial, grade I/II, photon
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.