RecruitingPhase 2NCT05964569

Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma

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


Sponsor

University Hospital Heidelberg

Enrollment

120 participants

Start Date

Nov 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying model-guided optimization of treatment plan and standard treatment plan, no optimization for people with low-grade glioma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERmodel-guided optimization of treatment plan

original treatmant plans are optimized based on model-based NTCP

OTHERstandard treatment plan, no optimization

original treatment plans are not optimized


Locations(1)

Department of Radiotherapy, University of Heidelberg

Heidelberg, Germany

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NCT05964569


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