Prospective Validation of Adaptive Radiotherapy (ART) in Patients With Head and Neck Tumors
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: Adaptive Radiotherapy.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Cancer, Adaptive Radiotherapy, Radiation, Optimized Treatment. 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
Adaptive Radiotherapy in the Treatment of Patients With a Histologically Confirmed Malignant Tumor in the Head and Neck Region: Prospective Validation of ART in Patients With HNT (Prospektive Validierung Der ART Bei Patientinnen Und Patienen Mit Kopf-Hals Tumoren,)
Обзор
Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical deviations. The shape and position constancy of the CTV during the course of the series is examined in this trial. Dosimetric disadvantages of this type have not been reported so far. The aim of this study is to identify patients who benefit from ART at an early stage and to select them for this method, and then to continue to offer ART to this patient group. If a relevant reduction in the minimum planning target volume (PTV) margins with ART compared to IGRT is demonstrated in this study, patients could be treated with ART.
Подробное описание
The aim here is to prospectively evaluate modern technical standards. In the last 25 years, radiotherapy has developed rapidly away from two-dimensional procedures towards volume-modulated, three-dimensional techniques. But here, too, there is a broad radiotherapeutic spectrum due to the high technical diversity in radiotherapy and ever newer technical innovations. (1) Definitive radiochemotherapy is standard of care for locally advanced head and neck tumors. The aim of this study is to monitor the influence of the new technical therapy standards (therapy options in application: volume-modulated rapid-arc technique (VMAT) / online onboard image-guidance (IGRT) and adaptive re-planning, using the linear accelerator ETHOS currently established and installed at the Department of Radiotherapy in December 2021) as a function of dose parameters for quality assurance of feasibility.
Therapy with ETHOS represents a comprehensive new treatment option that is tailored and individualized from the initial planning and adjustment on the treatment table to radiation monitoring of the whole therapy.
Online-adaptive radiotherapy (ART) allows the dose distribution to be adapted to the anatomical changes online and immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard of care in radiotherapy. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations of the body from radiation fraction to radiation fraction, e.g. through different positioning of the tongue or jaw.
This trial creates the basis for standardizing treatment parameters as far as possible, but also for introducing improvements in the treatment of future patients in a personalized and individualized form.
Standard therapy can be further optimized using modern equipment and high-precision linear accelerators.
Вмешательства
- Лучевая терапия Adaptive Radiotherapy
Adaptive Radiotherapy in the head and neck region
Первичные конечные точки
- Accumulated dose distribution in CTV [Срок оценки: 2 weeks]
Вторичные конечные точки (8)
- dysphagia assessment scores [Срок оценки: 2 weeks to 5 years]
- Minimally isotropic PTV margin [Срок оценки: 2 months]
- Progression free survival (PFS) [Срок оценки: 2 months to 5 years]
- overall survival (OS) [Срок оценки: 2 months to 5 years]
- dose organs at risk (OAR) [Срок оценки: 2 weeks]
- Side effects, LENT-SOMA [Срок оценки: 2 months to 5 years]
- quality of life (EORTC) [Срок оценки: 2 months to 5 years]
- Side effects (CTC AE) [Срок оценки: 2 months to 5 years]
Критерии участия
Критерии включения
- ECOG 0-1
- Histopathology confirmation
- Compliance
- Tumor in the head and neck region
- Indication for radiotherapy
Критерии исключения
1\. Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Германия · 1 центр
- Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases — Essen
Публикации
- Chetty IJ, Martel MK, Jaffray DA, Benedict SH, Hahn SM, Berbeco R, Deye J, Jeraj R, Kavanagh B, Krishnan S, Lee N, Low DA, Mankoff D, Marks LB, Ollendorf D, Paganetti H, Ross B, Siochi RA, Timmerman RD, Wong JW. Technology for Innovation in Radiation Oncology. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):485-92. doi: 10.1016/j.ijrobp.2015.07.007. Epub 2015 Jul 11. PMID 26460989
Идентификаторы
NCT: NCT06214611 · 23-11129-BO · DRKS00033144