Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

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Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04648462
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Maastricht Radiation Oncology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Danielle EekersDanielle EekersHiske van der WeideM KramerYvonne KlaverM KroesenA Mendez RomeroJ JaspersI CoremansJaap ZindlerInge Compter
Principal Investigator Affiliation	Maastro Clinic, The NetherlandsMaastro Clinic, The NetherlandsUMC GroningenUMC GroningenHollandPTCHollandPTCErasmus Medical CenterErasmus Medical CenterLeiden University Medical CenterMedical Center HaaglandenMaastro Clinic, The Netherlands
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma, Optic Nerve Glioma, Meningioma, Nerve Sheath Neoplasms, Adenoma, Craniopharyngioma, Hemangiopericytoma, Germinoma, Neurilemmoma

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