Standard Follow-up Program (SFP) for Head and Neck Cancer Patients
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: Radiotherapy (primary or postoperative).
- Кому может быть актуально
- Состояния в реестре: Head and Neck Cancer. 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
- Нидерланды
- 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
Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)
Обзор
The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.
Подробное описание
Specific objectives
* To develop, validate, and improve normal tissue complication probability (NTCP) models for a wide variety of acute and late radiation-induced side effects relevant for head and neck cancer patients (step 1); * To use the outcome of the NTCP models to better inform patients on the risks on acute and late toxicity; * To use the outcome of the NTCP models for the definition of dose constraints for radiotherapy treatment planning in current practice; * To use the outcome of the NTCP models for the development and investigation of the potential benefit of new and emerging radiation delivery technique, such as swallowing sparing intensity modulation radiation therapy (IMRT) and proton radiotherapy. * To compare the outcome of new radiation delivery techniques that are clinically introduced with the current standard in terms of radiation-induced toxicity, patient-rated symptoms and quality of life and in terms of locoregional tumour control and overall survival
Вмешательства
- Лучевая терапия Radiotherapy (primary or postoperative)
Первичные конечные точки
- Late toxicity [Срок оценки: At 6 months after last day of completion of treatment]
Вторичные конечные точки (12)
- Change in acute toxicity [Срок оценки: At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy]
- Change in patient-rated quality of life [Срок оценки: At 6,12,18,24,36,48,60 months after completion of treatment]
- Overall survival [Срок оценки: At 1,2,3,4 and 5 years after completion of treatment]
- Change in locoregional tumour control [Срок оценки: At 1,2,3,4 and 5 years after completion of treatment]
- Laryngo-oesophageal dysfunction-free survival [Срок оценки: At 1,2,3,4 and 5 years after completion of treatment]
- Change in patient-rated symptoms [Срок оценки: At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy]
- Late toxicity [Срок оценки: At 12 months after last day of completion of treatment]
- Late toxicity [Срок оценки: At 18 months after last day of completion of treatment]
- Late toxicity [Срок оценки: At 24 months after last day of completion of treatment]
- Late toxicity [Срок оценки: At 36 months after last day of completion of treatment]
- Late toxicity [Срок оценки: At 48 months after last day of completion of treatment]
- Late toxicity [Срок оценки: At 60 months after last day of completion of treatment]
Критерии участия
Критерии включения
- All patients planned for curatively intended primary or postoperative radiotherapy will be included. At the first visit, patients are informed about the standard follow up program by the treating physician.
Критерии исключения
- All patients planned for palliative radiotherapy will not be included in the SFP.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- University Medical Center Groningen — Groningen
Публикации
- van der Laan HP, Gawryszuk A, van der Schaaf A, Langendijk JA. Risk reduction of radiation-induced aspiration by sparing specific aspiration-related-organs at risk; an in silico feasibility study. Radiother Oncol. 2025 Feb;203:110698. doi: 10.1016/j.radonc.2024.110698. Epub 2024 Dec 21. PMID 39716592
Идентификаторы
NCT: NCT02435576 · SFP2007-03