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NCT Number: NCT04648462

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

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.

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Key information

Conditions

Astrocytoma Adenoma Central Nervous System Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Craniopharyngioma Ependymoma Eye Diseases Ganglioglioma Germinoma Glioma Hemangiopericytoma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neuroma Neuromuscular Diseases Oligodendroglioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Peripheral Nervous System Diseases Peripheral Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht Radiation Oncology, Maastricht, Limburg, Netherlands

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not eligible for chemotherapy
  • Eligible for stereotactic radiotherapy

Treatment and study plan

ProTRAIT

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. HVLT- delayed recall decline at 5 years

    Time frame: 5 years after radiotherapy

    HVLT- delayed recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

  2. HVLT total recall decline at 5 years

    Time frame: 5 years after radiotherapy

    HVLT total recall decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

  3. TMT a decline at 5 years

    Time frame: 5 years after radiotherapy

    TMT a decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

  4. TMT b decline at 5 years

    Time frame: 5 years after radiotherapy

    TMT b decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

  5. COWA total decline at 5 years

    Time frame: 5 years after radiotherapy

    COWA total decline of -1.5Z compared to baseline at 5 years, using the RCI method based on the normal data

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Eekers

CONTACT

[email protected]

+31884455600

Hiske van der Weide

CONTACT

[email protected]

+31503612711

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Erasmus Medical Center
  • HollandPTC
  • Leiden University Medical Center
  • Maastro Clinic, The Netherlands
  • Medical Center Haaglanden
  • University Medical Center Groningen

Registry information

Important dates

Study start
2018
Primary completion
2030
Study completion
2035
First posted
Dec 1, 2020
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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