Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
1 other identifier
observational
1,500
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
November 26, 2024
November 1, 2024
12 years
November 6, 2020
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
HVLT- delayed recall decline at 5 years
5 years after radiotherapy
HVLT total recall decline at 5 years
5 years after radiotherapy
TMT a decline at 5 years
5 years after radiotherapy
TMT b decline at 5 years
5 years after radiotherapy
COWA total decline at 5 years
5 years after radiotherapy
Interventions
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.
Eligibility Criteria
All neuro-oncological patients treated with proton therapy at one of the three proton centers in the Netherlands
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Radiation Oncologylead
- University Medical Center Groningencollaborator
- HollandPTCcollaborator
- Erasmus Medical Centercollaborator
- Leiden University Medical Centercollaborator
- Medical Center Haaglandencollaborator
- Maastro Clinic, The Netherlandscollaborator
Study Sites (3)
Maastricht Radiation Oncology
Maastricht, Limburg, 6202 AZ, Netherlands
Holland PTC
Delft, South Holland, 2629 JH, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 WS, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Eekers
Maastro Clinic, The Netherlands
- STUDY CHAIR
Danielle Eekers
Maastro Clinic, The Netherlands
- PRINCIPAL INVESTIGATOR
Hiske van der Weide
UMC Groningen
- PRINCIPAL INVESTIGATOR
M Kramer
UMC Groningen
- PRINCIPAL INVESTIGATOR
Yvonne Klaver
HollandPTC
- PRINCIPAL INVESTIGATOR
M Kroesen
HollandPTC
- PRINCIPAL INVESTIGATOR
A Mendez Romero
Erasmus Medical Center
- PRINCIPAL INVESTIGATOR
J Jaspers
Erasmus Medical Center
- PRINCIPAL INVESTIGATOR
I Coremans
Leiden University Medical Center
- PRINCIPAL INVESTIGATOR
Jaap Zindler
Medical Center Haaglanden
- PRINCIPAL INVESTIGATOR
Inge Compter
Maastro Clinic, The Netherlands
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
December 1, 2020
Study Start
January 1, 2018
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2035
Last Updated
November 26, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share