Optimizing Proton Beam Treatment for Low Grade Glioma
Official title: Prospective Phase II Trial to Assess Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma Multicentric, Prospective Interventional, Randomized, Observer Blind Two Arm (Active Control), Parallel Group Investigator-initiated Phase II Trial
Run by University Hospital Heidelberg · NCT05964569 · Data updated 2026-11-12
This study is testing a new way to plan proton beam treatment for people with low-grade glioma to see if it can improve results and reduce side effects compared to standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg) |
| Status | Recruiting |
| Started | November 11, 2023 |
| Main results expected | November 11, 2026 |
| Study ends | November 11, 2028 |
| Registry record updated | January 5, 2024 |
| Trial ID | NCT05964569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with histologically confirmed low-grade glioma who require radiotherapy.
✕Probably not a fit
Patients with previous cerebral irradiation or contraindications for MRI may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the feasibility of using individualized, model-guided optimization for proton beam treatment planning in patients diagnosed with low-grade glioma. The study aims to enhance treatment efficacy while minimizing long-term side effects associated with radiotherapy, such as neurocognitive decline and secondary tumors. Participants will receive either a model-optimized treatment plan or a standard treatment plan to assess the potential benefits of the new approach. The trial is particularly focused on understanding and mitigating the risk of late contrast-enhancing brain lesions that can occur post-treatment.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients by reducing treatment-related side effects.
How similar studies have gone: While large randomized trials are lacking, smaller studies have shown promising results for similar model-guided treatment approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * histologically proven low-grade glioma * indication for definitive or adjuvant radiotherapy * ability to understand character and personal consequences of the clinical trial * written informed consent Exclusion Criteria: * previous cerebral irradiation * contraindication for contrast-enhanced MRI * neurofibromatosis * participation in another clinical trial with competing objectives
Where it's running
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Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany Recruiting
Study contacts
- Study coordinator: Semi Harrabi, MD
- Email: semi.harrabi@med.uni-heidelberg.de
- Phone: +496221 56
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.