Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Not eligible for chemotherapy treatment
- Eligible for stereotactic radiotherapy
AI-Screening
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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
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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