Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: model-guided optimization of treatment plan, standard treatment plan, no optimization.
- Who it may be relevant to
- Registry conditions: Low Grade Glioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Detailed description
Since patients with low grade glioma are expected to become long-term survivors, the prevention of long-term sequelae is particularly important. In addition to disease progression, also treatment related side effects such as decline of neurocognitive function, endocrine impairment or sensorineural deficits can have a negative impact on patient's quality of life.
Owing to the biophysical properties of protons with an inverse depth dose profile compared to photons and a steep dose fall of to the normal tissue, there is a strong rationale for the use of PRT in the treatment of patients with low-grade glioma. Although data from large randomized trials are still missing there is increasing evidence from smaller prospective trials and retrospective analyses that the expected advantages indeed transform into clinical advantages.
However, in about 20 % of all patients, late contrast-enhancing brain lesions (CEBL) appear on follow-up MR images 6 - 24 months after treatment. At HIT in Heidelberg and at OncoRay in Dresden, CEBLs have been observed to occur at very distinct locations in the brain and relative to the treatment field. Retrospective analysis has elucidated potential key factors that lead to CEBL occurrence. However, avoidance of CEBLs is hardly feasible using conventional treatment planning strategies. Model-aided risk avoidance denotes the use of model-based CEBL risk calculations as an auxiliary tool for clinical treatment planning: Model-based risk calculations and risk reduction via software-based optimization help the clinician to minimize risk of CEBL occurrence during treatment planning.
Interventions
- Other model-guided optimization of treatment plan
original treatmant plans are optimized based on model-based NTCP - Other standard treatment plan, no optimization
original treatment plans are not optimized
Primary outcome measures
- incidence of contrast enhancing brain leasions [Time frame: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain]
Secondary outcome measures (6)
- radiation-induced brain injuries [Time frame: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain]
- progression-free survival [Time frame: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain]
- overall survival [Time frame: observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain]
- patient reported outcome [Time frame: up to 24 months after completion of radiotherapy]
- quality of life QLQ-C30 [Time frame: up to 24 months after completion of PRT]
- quality of life QLQ-BN20 [Time frame: up to 24 months after completion of PRT]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Department of Radiotherapy, University of Heidelberg — Heidelberg
Publications
- Sallem H, Harrabi S, Traneus E, Herfarth K, Debus J, Bauer J. A model-based risk-minimizing proton treatment planning concept for brain injury prevention in low-grade glioma patients. Radiother Oncol. 2024 Dec;201:110579. doi: 10.1016/j.radonc.2024.110579. Epub 2024 Oct 10. PMID 39393467
Identifiers
NCT: NCT05964569 · RadOnk-Indigo