Clinical trial NCT04648462: Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
Official title: Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Astrocytoma
Ependymoma
Ganglioglioma
Oligodendroglioma
Optic Nerve Glioma
Meningioma
Nerve Sheath Neoplasms
Adenoma
Craniopharyngioma
Hemangiopericytoma
Germinoma
Neurilemmoma
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: HollandPTC
name: Erasmus Medical Center
name: Leiden University Medical Center
name: Medical Center Haaglanden
name: Maastro Clinic, The Netherlands
First posted: 2020-12-01
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neuro-oncological patients treated with proton therapy at one of the three proton centers in the Netherlands

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

Primary outcomes:
measure: Neurocognitive failure at 5 years
timeFrame: 5 years after radiotherapy
Secondary outcomes:
measure: HVLT- delayed recall decline at 5 years
timeFrame: 5 years after radiotherapy
measure: HVLT total recall decline at 5 years
timeFrame: 5 years after radiotherapy
measure: TMT a decline at 5 years
timeFrame: 5 years after radiotherapy
measure: TMT b decline at 5 years
timeFrame: 5 years after radiotherapy
measure: COWA total decline at 5 years
timeFrame: 5 years after radiotherapy
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology
state: Limburg
city: Delft
country: Netherlands
facility: Holland PTC
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Danielle Eekers
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastro Clinic, The Netherlands
name: Danielle Eekers
role: STUDY_CHAIR
affiliation: UMC Groningen
name: Hiske van der Weide
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Groningen
name: M Kramer
role: PRINCIPAL_INVESTIGATOR
affiliation: HollandPTC
name: Yvonne Klaver
role: PRINCIPAL_INVESTIGATOR
affiliation: HollandPTC
name: M Kroesen
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: A Mendez Romero
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: J Jaspers
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: I Coremans
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center Haaglanden
name: Jaap Zindler
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastro Clinic, The Netherlands
name: Inge Compter
role: PRINCIPAL_INVESTIGATOR
References: