NCT05964569 Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
| NCT ID | NCT05964569 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital Heidelberg |
| Condition | Low Grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-11-11 |
| Primary Completion | 2026-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-11-11 with a primary completion date of 2026-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Low-grade glioma (LGG) represent typically slowly growing primary brain tumors with world health organization (WHO) grade I or II who affect young adults around their fourth decade. Radiological feature on MRI is a predominantly T2 hyperintense signal, LGG show typically no contrast uptake. Radiotherapy plays an important role in the treatment of LGG. However, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. In order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05964569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05964569 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05964569 currently recruiting?
Yes, NCT05964569 is actively recruiting participants. Contact the research team at semi.harrabi@med.uni-heidelberg.de for enrollment information.
Where is the NCT05964569 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT05964569 clinical trial?
NCT05964569 is sponsored by University Hospital Heidelberg. The trial plans to enroll 120 participants.