Набор скоро начнётся NCT07671768

Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial

Без фазы С лечением Metastatic Malignant Solid Neoplasm

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: Computed Tomography, Magnetic Resonance Imaging, MRI-guided Stereotactic Body Radiation Therapy, Positron Emission Tomography.
Кому может быть актуально: Состояния в реестре: Metastatic Malignant Solid Neoplasm. 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

ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors

Обзор

This clinical trial studies the side effects of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over 1-5 days. This type of radiation therapy helps spare normal tissue. During MR-guided SBRT, MR imaging is used to define and localize the area to be treated and provide more accurate delivery. This allows the treatment to be given over one day. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors. Tumors in the central nervous system will not be treated on this study.

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate the incidence of acute grade ≥ 3 adverse events that are possibly, probably, or definitely related to single-fraction adaptive MR-guided SBRT.

SECONDARY OBJECTIVES:

I. To estimate local control (LC), progression-free survival (PFS) and overall survival (OS).

II. To characterize late grade ≥ 3 toxicity rates per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To assess patient-reported health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) at baseline, end of treatment, 3 months post-treatment, and 1 year post-treatment.

IV. To measure total in-room time, defined as the duration from patient entry to exit at the treatment console.

OUTLINE:

Patients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) on study and CT or PET/CT throughout the study.

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

Вмешательства

Процедура Computed Tomography
Undergo CT and/or PET/CT
Процедура Magnetic Resonance Imaging
Undergo MRI
Лучевая терапия MRI-guided Stereotactic Body Radiation Therapy
Undergo MR-guided SBRT
Процедура Positron Emission Tomography
Undergo PET/CT
Другое Questionnaire Administration
Ancillary studies

Первичные конечные точки

Acute toxicity rate [Срок оценки: Up to 3 months post-radiation therapy]

Вторичные конечные точки (6)

Time to local failure (Local control) [Срок оценки: From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months]
Progression-free survival [Срок оценки: From end of study treatment to the first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months]
Overall survival [Срок оценки: From end of study treatment to death from any cause, assessed up to 12 months]
Incidence of late grade ≥ 3 toxicities [Срок оценки: From 3 months post-radiation therapy up to 12 months post-radiation therapy]
PROMIS-29 patient-reported health-related quality-of-life (HRQOL) [Срок оценки: Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment]
Total in-room time [Срок оценки: From patient entry to exit at the treatment console, approximately one day]

Критерии участия

Критерии включения

Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) 0-2
Histologically confirmed metastatic solid tumor (any primary site)
1-3 metastases ≤ 5 cm each located outside the brain and spine
Lesions treatable at 25-30 Gy × 1 fraction with MR guidance
No overlapping prior radiation
Absolute neutrophil count (ANC) > 1.5 cell/mm\^3
Hemoglobin (Hgb) > 8.0 gm/dL
Platelet (PLT) > 150,000/mm\^3
Total bilirubin < or equal to 1.5 x upper limit of normal
Aspartate aminotransferase (AST) < or equal to three times upper limit of normal
Alanine aminotransferase (ALT) < or equal to three times upper limit of normal
Informed consent obtained