NCT04648462 Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
| NCT ID | NCT04648462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht Radiation Oncology |
| Condition | Astrocytoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2018-01-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. All brain tumors with a favorable prognosis (median survival \> 10 year) 2. Age ≥ 18 years 3. ECOG performance status 0 - 1 / Karnofsky performance status 80 - 100 4. No - minimal neurocognitive impairment 5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi) 6. Informed consent Exclusion Criteria: 1. Not eligible for chemotherapy 2. Eligible for stereotactic radiotherapy
Contact & Investigator
Danielle Eekers
PRINCIPAL INVESTIGATOR
Maastro Clinic, The Netherlands
Frequently Asked Questions
Who can join the NCT04648462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Astrocytoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04648462 currently recruiting?
Yes, NCT04648462 is actively recruiting participants. Contact the research team at danielle.eekers@maastro.nl for enrollment information.
Where is the NCT04648462 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Delft, Netherlands, Groningen, Netherlands.
Who is sponsoring the NCT04648462 clinical trial?
NCT04648462 is sponsored by Maastricht Radiation Oncology. The principal investigator is Danielle Eekers at Maastro Clinic, The Netherlands. The trial plans to enroll 1,500 participants.