Registry Maastro Applicator
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Rectal 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
Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
Обзор
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
Подробное описание
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watch-and-wait strategy, which avoids surgery and improves quality of life by preventing complications such as incontinence or the need for a stoma.
Increasing the radiation dose improves the chance of achieving a CR. Endoluminal boost techniques-high-dose-rate (HDR) brachytherapy and contact X-ray radiotherapy (CXRT)-allow a highly localized radiation boost. CXRT has shown higher CR rates than external beam radiotherapy (EBRT) boosts (81% vs. 60%). However, widespread use of endoluminal boosting is limited by the high cost of CXRT equipment and the less favorable dose distribution of HDR brachytherapy.
To overcome these limitations, MAASTRO, in collaboration with Varian Inc., developed a new HDR rectal brachytherapy applicator that delivers a dose profile similar to CXRT. The applicator has received CE certification and is now available for clinical use. A recent clinical trial confirmed that treatment with this applicator is clinically feasible. As a result, MAASTRO HDR treatment is now part of standard care.
To improve understanding of treatment outcomes and optimize future strategies, a prospective observational cohort study has been initiated.This project is designed to continuously include new patients and will provide an ongoing source for multiple future studies
Первичные конечные точки
- Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum. [Срок оценки: From enrollment to the end of FU at 10 years]
- Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view. [Срок оценки: During treatment]
- Duration of the application procedure. [Срок оценки: During treatment]
- Clinical complete response rate up to 5 years after treatment. [Срок оценки: From end of treatment until 5 years after treatment]
- Toxcity up to 3 year after treatment [Срок оценки: From start treatment until 3 years after the end of treatment]
- Disease status up to 10 years after treatment [Срок оценки: from enrollment until 10 years after treatment]
- Salvage surgery [Срок оценки: From end of treatment until 5 years after treatment]
- Overall and disease specific survival rate [Срок оценки: from enrollment until 10 years after treatment]
- Discomfort/pain [Срок оценки: From baseline up to 2 weeks after last fraction]
Вторичные конечные точки (3)
- Health status [Срок оценки: From enrollment until 5 years after treatment]
- Long-term rectal functional outcome [Срок оценки: From enrollment until 5 years after treatment]
- Quality of life questionnaires [Срок оценки: From enrollment until 5 years after treatment]
Критерии участия
Критерии включения
- Age ≥ 18 years.
- Histological proof of rectal cancer, or a strong suspicion after imaging.
- Treatment with MAASTRO HDR rectal applicator
- Informed consent for longitudinal observational data collection.
Критерии исключения
- Mentally incompetent patients.
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
- Maastro — Maastricht
Идентификаторы
NCT: NCT07501845 · Registry Maastro Applicator