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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

previous cerebral irradiation

contraindication for contrast-enhanced MRI

neurofibromatosis

participation in another clinical trial with competing objectives

Trial design

Design model

Parallel

Treatments tested in this trial

  • model-guided optimization of treatment plan

    Other intervention

    original treatmant plans are optimized based on model-based NTCP

  • standard treatment plan, no optimization

    Other intervention

    original treatment plans are not optimized

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard treatment planActive comparator 1 intervention
Group B: Optimized treatment planExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

incidence of contrast enhancing brain leasions

the cumulative incidence of contrast enhancing brain lesions

Time frame
observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain

Secondary outcomes

1

radiation-induced brain injuries

incidence of radiation-induced brain injuries \> CTC°II

Time frame
observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
2

progression-free survival

number of surviving patients without tumor progression

Time frame
observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
3

overall survival

number of surviving patients

Time frame
observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain
4

patient reported outcome

patient reported outcome according to points on the PRO-CTCAE questionaire, scored 0/1 for absent/present)

Time frame
up to 24 months after completion of radiotherapy

Other outcomes

Sponsors and contacts

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