CONFIRM: Magnetic Resonance Guided Radiation Therapy
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: Viewray MRIdian® Linac.
- Кому может быть актуально
- Состояния в реестре: Gastric Cancer, Invasive Breast Cancer, in Situ Breast Cancer, Mantle Cell Lymphoma. 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
- США
- 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
Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol
Обзор
This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.
Подробное описание
This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.
In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.
The research study procedures include:
* Screening for eligibility * Study treatment including evaluations * Follow up visits * Questionnaires
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied.
This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation. Investigators at other hospitals and academic centers are already using this type of radiation.
The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.
Вмешательства
- Лучевая терапия Viewray MRIdian® Linac
MR-image guided radiation will be administered per disease site standards.
Первичные конечные точки
- Number of Patients and delivering MR-image guided radiation-Phase I [Срок оценки: 5 weeks]
- Tumor Assessment with MR Guidance-Phase I [Срок оценки: 5 weeks]
- Patient reported outcomes (PROMs) -Phase II [Срок оценки: 1 year]
- 1-year tumor control-Phase II [Срок оценки: 1 year]
- Rate of Pathologic complete response-Gastric [Срок оценки: 1 year]
Вторичные конечные точки (7)
- Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0. [Срок оценки: 90 Days]
- Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0. [Срок оценки: 1 year]
- Duration of treatment with goal of >80% of cases treated within 90 minutes [Срок оценки: 7 weeks]
- Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation. [Срок оценки: 5 Weeks]
- Progression Free Survival [Срок оценки: irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months]
- Overall Survival [Срок оценки: irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year]
- Characterizing MRI-based tumor alterations/changes following MR-image guided radiation [Срок оценки: 1 Year]
Критерии участия
Критерии включения
- Participants must have histologically or cytologically confirmed malignancy requiring radiation
- Age 18 years of older
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Any further criteria listed in the specific disease site cohort
Критерии исключения
- History of allergic reactions attributed to gadolinium-based IV contrast
\-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility
- Severe claustrophobia or anxiety
- Participants who cannot undergo an MRI
- Any other exclusion criteria listed in the specific disease site cohort
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- Brigham & Women's Hospital — Boston
- Dana Farber Cancer Institute — Boston
Идентификаторы
NCT: NCT04368702 · 19-665