Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

  • STATUS
    Recruiting
  • End date
    Jan 1, 2035
  • participants needed
    1500
  • sponsor
    Maastricht Radiation Oncology
Updated on 4 May 2022
karnofsky performance status
proton therapy

Summary

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.

Details
Condition Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma, Nerve Sheath Neoplasms, Adenoma, Craniopharyngioma, Hemangiopericytoma, Germinoma, Neurilemmoma
Treatment ProTRAIT
Clinical Study IdentifierNCT04648462
SponsorMaastricht Radiation Oncology
Last Modified on4 May 2022

Eligibility

Yes No Not Sure

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
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