Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT04648462

Run by

Maastricht Radiation Oncology

People needed

1500

Starts

2018-01-01

Expected to finish

2035-01-01

Last updated by the study team

2024-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Not eligible for chemotherapy
• Eligible for stereotactic radiotherapy

Where it is running

• Maastricht Radiation Oncology — Maastricht, Limburg, Netherlands (enrolling)
• Holland PTC — Delft, South Holland, Netherlands (enrolling)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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