Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

NCT ID: NCT04648462

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2035-01-01

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.

Conditions

Astrocytoma; Ependymoma; Ganglioglioma; Oligodendroglioma; Optic Nerve Glioma; Meningioma; Nerve Sheath Neoplasms; Adenoma; Craniopharyngioma; Hemangiopericytoma; Germinoma; Neurilemmoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ProTRAIT

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

HollandPTC

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

Maastro Clinic, The Netherlands

OTHER

Sponsor Role: collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Eekers

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Danielle Eekers

Role: STUDY_CHAIR

Maastro Clinic, The Netherlands

Hiske van der Weide

Role: PRINCIPAL_INVESTIGATOR

UMC Groningen

M Kramer

Role: PRINCIPAL_INVESTIGATOR

UMC Groningen

Yvonne Klaver

Role: PRINCIPAL_INVESTIGATOR

HollandPTC

M Kroesen

Role: PRINCIPAL_INVESTIGATOR

HollandPTC

A Mendez Romero

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

J Jaspers

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

I Coremans

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Jaap Zindler

Role: PRINCIPAL_INVESTIGATOR

Medical Center Haaglanden

Inge Compter

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Locations

Maastricht Radiation Oncology

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Holland PTC

Delft, South Holland, Netherlands

Site Status: RECRUITING

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Danielle Eekers

Role: CONTACT

danielle.eekers@maastro.nl

+31884455600

Hiske van der Weide

Role: CONTACT

h.l.van.der.weide@umcg.nl

+31503612711

Facility Contacts

Danielle Eekers

Role: primary

danielle.eekers@maastro.nl

+31884455600

Inge Compter

Role: backup

inge.compter@maastro.nl

+31884455600

Yvonne Klaver

Role: primary

y.klaver@hollandptc.nl

+31885011100

Jaap Zindler

Role: backup

j.zindler@hollandptc.nl

+31885011100

Hiske van der Weide

Role: primary

h.l.van.der.weide@umcg.nl

+31503612711

Miranda Kramer

Role: backup

m.c.a.kramer@umcg.nl

+31503612711

Other Identifiers

ProTRAIT-neuro

Identifier Type: -

Identifier Source: org_study_id