Actively Recruiting

Age: 18Years +
All Genders
ID04648462

Proton Therapy Research Infrastructure ProTRAIT for Neuro-oncology Patients

Led by Maastricht Radiation Oncology · Updated on 2024-11-26

1500

Participants Needed

3

Research Sites

260 weeks

Total Duration

On this page

Sponsors

M

Maastricht Radiation Oncology

Lead Sponsor

U

University Medical Center Groningen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the use of proton therapy for treating certain brain tumors with a favorable prognosis. Proton therapy has the potential to reduce radiation exposure to healthy tissues compared to traditional photon therapy, which may lower the risk of radiation-induced complications and secondary tumors. This research follows a model-based approach to select patients who might benefit from proton therapy by comparing individual treatment plans and predicting clinical benefit using Normal Tissue Complication Probability models. The study is observational and collects standardized data from Dutch patients receiving proton or photon therapy. Participants receive follow-up care at outpatient clinics with evaluations by physicians, physician assistants, or trial nurses. Follow-up visits are scheduled at 2.5, 5, 7.5, and 10 years after radiotherapy. The study infrastructure supports collecting clinical data, 3D imaging, and dosimetry information to continuously update and validate prediction models related to proton therapy in neuro-oncology. During the study, researchers monitor neurocognitive function and record outcomes such as neurocognitive failure and memory recall declines at five years post-radiotherapy. Participants undergo regular assessments and data collection during scheduled visits. The study aims to improve the understanding of proton therapy's effects on brain tumors, with long-term follow-up extending up to 10 years after treatment.

CONDITIONS

Brief Title

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of brain tumors with a favorable prognosis (median survival greater than 10 years)
  • ECOG performance status 0 to 1 or Karnofsky performance status 80 to 100
  • No or minimal neurocognitive impairment
  • Dosimetrical advantage of proton therapy compared to photon therapy (at least 5% dose reduction on supratentorial brain or hippocampi)
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Not eligible for chemotherapy
  • Eligible for stereotactic radiotherapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years after radiotherapy

Participants are seen at the outpatient clinic by a physician, physician assistant, or trial nurse at standard follow-up times after radiotherapy to monitor neurocognitive function and other outcomes.

Visits at 2.5, 5, 7.5, and 10 years after radiotherapy

Trial Site Locations

Total: 3 locations

1

Maastricht Radiation Oncology

Maastricht, Limburg, Netherlands, 6202 AZ

Actively Recruiting

2

Holland PTC

Delft, South Holland, Netherlands, 2629 JH

Actively Recruiting

3

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 WS

Actively Recruiting

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Research Team

D

Danielle Eekers

H

Hiske van der Weide

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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