Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

April 12, 2022 updated by: Maastricht Radiation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 WS
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
    • Zuid-Holland
      • Delft, Zuid-Holland, Netherlands, 2629 JH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years after radiotherapy
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
5 years after radiotherapy
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
5 years after radiotherapy
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 years after radiotherapy
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
5 years after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Collaborators

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

Investigators

  • Principal Investigator: Danielle Eekers, Maastro Clinic, The Netherlands
  • Study Chair: Danielle Eekers, Maastro Clinic, The Netherlands
  • Principal Investigator: Hiske van der Weide, UMC Groningen
  • Principal Investigator: M Kramer, UMC Groningen
  • Principal Investigator: Yvonne Klaver, HollandPTC
  • Principal Investigator: M Kroesen, HollandPTC
  • Principal Investigator: A Mendez Romero, Erasmus Medical Center
  • Principal Investigator: J Jaspers, Erasmus Medical Center
  • Principal Investigator: I Coremans, Leiden University Medical Center
  • Principal Investigator: Jaap Zindler, Medical Center Haaglanden
  • Principal Investigator: Inge Compter, Maastro Clinic, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

January 1, 2035

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProTRAIT-neuro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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