Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Not eligible for chemotherapy
- Eligible for stereotactic radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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