Идёт набор NCT07223307

REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Фаза II С лечением Liver Cancer Intrahepatic Cholangiocarcinoma Liver Metastases HCC

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: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR).
Кому может быть актуально: Состояния в реестре: Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases, HCC. 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 →

Официальное название

Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow

Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers

Лучевая терапия MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40

Вторичные конечные точки (7)

Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events [Срок оценки: Within 90 days of completing SABR]
Rate of Grade ≥ 2 Radiation Pneumonitis [Срок оценки: Within 90 days of completing SABR]
Rate of Grade ≥ 2 Chest Wall Toxicity [Срок оценки: Within 90 days of completing SABR]
Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR [Срок оценки: Up to 1 year post-SABR]
Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR [Срок оценки: Up to 1 year post-SABR]
Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR [Срок оценки: Up to 1 year post-SABR]
Rate of Patients With Total Delivery Time > 120 Minutes [Срок оценки: Baseline]

Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion > 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
≥ 18 years old at time of study enrollment
Child-Pugh A status
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Life Expectancy > 6 months
For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.
Ability to understand and the willingness to provide written informed consent.
Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria