Actively Recruiting

Age: 18Years +
All Genders
NCT04648462

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Led by Maastricht Radiation Oncology · Updated on 2024-11-26

1500

Participants Needed

3

Research Sites

887 weeks

Total Duration

On this page

Sponsors

M

Maastricht Radiation Oncology

Lead Sponsor

U

University Medical Center Groningen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with brain tumors that have a favorable prognosis with median survival more than 10 years
  • ECOG performance status between 0 and 1 or Karnofsky performance status between 80 and 100
  • No or minimal neurocognitive impairment
  • Demonstrated dosimetric benefit of proton therapy compared to photon therapy (at least 5% reduction in dose to supratentorial brain or hippocampi)
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Not eligible for chemotherapy treatment
  • Eligible for stereotactic radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Maastricht Radiation Oncology

Maastricht, Limburg, Netherlands, 6202 AZ

Actively Recruiting

2

Holland PTC

Delft, South Holland, Netherlands, 2629 JH

Actively Recruiting

3

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 WS

Actively Recruiting

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Research Team

D

Danielle Eekers

CONTACT

H

Hiske van der Weide

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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