AstrocytomaNCT04648462
Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
An observational study of Astrocytoma and Ependymoma, run by Maastricht Radiation Oncology at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Ependymoma, Ganglioglioma
- What is being tested?
- ProTRAIT
- How many people
- 1,500 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jan 2018to 1 Jan 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All neuro-oncological patients treated with proton therapy at one of the three proton centers in the Netherlands
Who may be able to join
- 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
Who cannot join
- Not eligible for chemotherapy
- Eligible for stereotactic radiotherapy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Holland PTC
Delft, South Holland, 2629 JH
Yvonne Klaver, +31885011100, y.klaver@hollandptc.nl
Jaap Zindler, +31885011100, j.zindler@hollandptc.nl
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, 9713 WS
Hiske van der Weide, +31503612711, h.l.van.der.weide@umcg.nl
Miranda Kramer, +31503612711, m.c.a.kramer@umcg.nl
- Recruiting
Maastricht Radiation Oncology
Maastricht, Limburg, 6202 AZ
Danielle Eekers, +31884455600, danielle.eekers@maastro.nl
Inge Compter, +31884455600, inge.compter@maastro.nl
About this study
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
- Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma
- Being tested
- ProTRAIT
- Medical subject headings
- Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma, Nerve Sheath Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTRAITOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years after radiotherapy
Secondary outcomes (5)
HVLT- delayed recall decline at 5 years
HVLT- delayed recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data
Measured: 5 years after radiotherapy
HVLT total recall decline at 5 years
HVLT total recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data
Measured: 5 years after radiotherapy
TMT a decline at 5 years
TMT a decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data
Measured: 5 years after radiotherapy
TMT b decline at 5 years
TMT b decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data
Measured: 5 years after radiotherapy
COWA total decline at 5 years
COWA total decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data
Measured: 5 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, HollandPTC, Erasmus Medical Center, Leiden University Medical Center, Medical Center Haaglanden, Maastro Clinic, The Netherlands
- Responsible party
- Sponsor
- Investigators
- Danielle Eekers, Principal investigator, Maastro Clinic, The NetherlandsDanielle Eekers, Study chair, Maastro Clinic, The NetherlandsHiske van der Weide, Principal investigator, UMC GroningenM Kramer, Principal investigator, UMC GroningenYvonne Klaver, Principal investigator, HollandPTCM Kroesen, Principal investigator, HollandPTCA Mendez Romero, Principal investigator, Erasmus Medical CenterJ Jaspers, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648462
- Sponsor's protocol ID
- ProTRAIT-neuro
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
- ClinicalTrials.gov ID
- NCT04648462
- Acronym / sponsor ID
- ProTRAIT-neuro
- Conditions
- Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, HollandPTC, Erasmus Medical Center, Leiden University Medical Center, Medical Center Haaglanden, Maastro Clinic, The Netherlands
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All neuro-oncological patients treated with proton therapy at one of the three proton centers in the Netherlands
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Not eligible for chemotherapy
- Eligible for stereotactic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProTRAITThe 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. | Other | – |
Primary outcome
Neurocognitive failure at 5 years
Time frame: 5 years after radiotherapy
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 secondary outcomes
HVLT- delayed recall decline at 5 years
Time frame: 5 years after radiotherapy
HVLT total recall decline at 5 years
Time frame: 5 years after radiotherapy
TMT a decline at 5 years
Time frame: 5 years after radiotherapy
TMT b decline at 5 years
Time frame: 5 years after radiotherapy
COWA total decline at 5 years
Time frame: 5 years after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle Eekers principal investigator
Maastro Clinic, The Netherlands
Danielle Eekers study chair
Maastro Clinic, The Netherlands
Hiske van der Weide principal investigator
UMC Groningen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astrocytoma and Ependymoma, run by Maastricht Radiation Oncology at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Eekers (+31884455600, danielle.eekers@maastro.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive failure at 5 years (time frame: 5 years after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.