Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Study Overview
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Brief Summary
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The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.

Official Title
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Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Conditions
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Adenoma, Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma, Nerve Sheath Neoplasms, Craniopharyngioma, Hemangiopericytoma, Germinoma, Neurilemmoma

Intervention / Treatment
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* Other: ProTRAIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All brain tumors with a favorable prognosis (median survival > 10 year) Age ≥ 18 years ECOG performance status 0 - 1 / Karnofsky performance status 80 - 100 No - minimal neurocognitive impairment Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi) Informed consent Exclusion Criteria: Not eligible for chemotherapy Eligible for stereotactic radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ProTRAIT|The participants are seen at the outpatient clinic by a physician, physician assistant or trial nurse at standard follow-up times at 2.5, 5, 7.5 and 10 years after radiotherapy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive failure at 5 years | Time to neurocognitive failure, defined as the time from last radiotherapeutic treatment to the first instance of a measured HVLT-dr of -1.5Z based on the normal data | 5 years after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HVLT- delayed recall decline at 5 years | HVLT- delayed recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy | 
| HVLT total recall decline at 5 years | HVLT total recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy | 
| TMT a decline at 5 years | TMT a decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy | 
| TMT b decline at 5 years | TMT b decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy | 
| COWA total decline at 5 years | COWA total decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data | 5 years after radiotherapy |