Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)
1 other identifier
interventional
555
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
December 16, 2024
December 1, 2024
11.3 years
May 11, 2016
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
late toxicity as cumulative measure
Events for the endpoint are: 1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions) 2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by \>10% 3. decrease in brain function (MOCA test) by more than 10%
1 year (or at least 6 months)
Secondary Outcomes (4)
Local tumour control
1 year and 2 years
Overall survival
1 year and 2 years
Acute toxicity
3 months after treatment
late toxicity as cumulative measure
2 years
Study Arms (8)
supratentorial, grade III/IV, photon
ACTIVE COMPARATORRadiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
supratentorial, grade III/IV, proton
EXPERIMENTALRadiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
supratentorial, grade I/II, photon
ACTIVE COMPARATORRadiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients, bening tumors.
supratentorial, grade I/II, proton
EXPERIMENTALRadiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients, bening tumors.
infratentorial, photon
ACTIVE COMPARATORRadiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
infratentorial, proton
EXPERIMENTALRadiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
pre-radiation, photon
ACTIVE COMPARATOR\> 40Gy in the region of recurrence. Radiation with photons normofractionated 54-60 Gy(RBE) or 5 Gy(RBE)/fraction until 30 Gy(RBE) or normofractionated 36 Gy(RBE).
pre-radiation, proton
EXPERIMENTAL\> 40Gy in the region of recurrence. Radiation with protons normofractionated 54-60 Gy(RBE) or 5 Gy(RBE)/fraction until 30 Gy(RBE) or normofractionated 36 Gy(RBE).
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
Dresden, 01307, Germany
University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology
Marburg, 35043, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mechthild Krause, Prof.
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 11, 2016
First Posted
July 7, 2016
Study Start
July 1, 2016
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2029
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share