Clinical trial NCT02824731: Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)
Official title: Comparison of Proton and Photon Radiotherapy of Brain Tumors: Efficiency and Side Effects in Clinical Standard Doses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumors
Keywords: brain tumors
proton radiotherapy
photon radiotherapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
name: National Center for Radiation Research in Oncology Dresden/Heidelberg
First posted: 2016-07-07
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Non-randomised 2-arm phase II trial on comparison of proton versus photon radiotherapy in brain tumours using standard doses and standard combined chemotherapy protocols. Patients are assigned to the treatment groups by their own choice or availability of the treatment. Patients are stratified into 4 groups, (1) supratentorial grad III/ IV tumours without pre-irradiation; (2) supratentorial grade I/II tumours without pre-irradiation; (3) infratentorial tumours without pre-irradiation; (4) patients with pre-irradiation \>40 Gy in the tumour area. Radiotherapy doses of 54-60 Gy(RBE) are applied in group 1-3 using normal fractionated schedules. In group 4, 30 Gy(RBE)/ 5 Gy(RBE) per fraction or 36 Gy(RBE) with 2 Gy(RBE) per fraction are allowed. Primary endpoint is chronic toxicity and quality of life. 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. Events for chronic toxicity are toxicities observed later than 3 months after end of radiotherapy and scored CTC-AE4.0 \>grade 2 or a decrease in Quality of life by \>10% (EORTC-QLQ C30 and BN20) or a decrease in neuropsychological functioning by \>10% (MoCa test). All statistical calculations apply to group (1), i.e. supratentorial grade II/IV tumours without pre-irradiation, all other arms are closed when group (1) is closed.

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

Primary outcomes:
measure: late toxicity as cumulative measure
timeFrame: 1 year (or at least 6 months)
Secondary outcomes:
measure: Local tumour control
timeFrame: 1 year and 2 years
measure: Overall survival
timeFrame: 1 year and 2 years
measure: Acute toxicity
timeFrame: 3 months after treatment
measure: late toxicity as cumulative measure
timeFrame: 2 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
city: Marburg
country: Germany
facility: University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology
Study officials:
affiliation: University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
name: Mechthild Krause, Prof.
role: STUDY_CHAIR
References: