Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: model-guided optimization of treatment plan, standard treatment plan, no optimization.
- Кому может быть актуально
- Состояния в реестре: Low Grade Glioma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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
Подробное описание
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.
Вмешательства
- Другое model-guided optimization of treatment plan
original treatmant plans are optimized based on model-based NTCP - Другое standard treatment plan, no optimization
original treatment plans are not optimized
Первичные конечные точки
- incidence of contrast enhancing brain leasions [Срок оценки: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain]
Вторичные конечные точки (6)
- radiation-induced brain injuries [Срок оценки: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain]
- progression-free survival [Срок оценки: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain]
- overall survival [Срок оценки: observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain]
- patient reported outcome [Срок оценки: up to 24 months after completion of radiotherapy]
- quality of life QLQ-C30 [Срок оценки: up to 24 months after completion of PRT]
- quality of life QLQ-BN20 [Срок оценки: up to 24 months after completion of PRT]
Критерии участия
Критерии включения
- 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
Критерии исключения
- previous cerebral irradiation
- contraindication for contrast-enhanced MRI
- neurofibromatosis
- participation in another clinical trial with competing objectives
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Германия · 1 центр
- Department of Radiotherapy, University of Heidelberg — Heidelberg
Публикации
- 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
Идентификаторы
NCT: NCT05964569 · RadOnk-Indigo