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Идёт набор NCT07429422

SBRT Technique Implementation for Spinal Metastases Irradiation

Без фазы С лечением Spinal Metastases Spinal Tumors Bone Metastases

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: Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases.
Кому может быть актуально
Состояния в реестре: Spinal Metastases, Spinal Tumors, Bone Metastases. 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
Словения
Следующий шаг
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Официальное название

Program SBRT Technique Implementation in Spinal Metastases Irradiation

Обзор

Stereotactic body radiotherapy (SBRT) is a highly precise, image-guided radiotherapy technique delivering 1-5 high-dose fractions to spinal metastases. Compared with conventional radiotherapy, SBRT enables delivery of a higher biologically effective dose while maintaining high precision. The Institute of Oncology Ljubljana initiated spinal SBRT treatments in 2017 and introduced an institutional SBRT spine protocol in 2019. As SBRT is technically demanding, strict adherence to standardized planning and delivery procedures is essential to ensure treatment quality and patient safety. This clinical program aims to support structured implementation and continuous development of the institutional SBRT spine protocol in routine clinical practice. The study prospectively evaluates treatment-related toxicity and local tumor control following SBRT for spinal metastases in order to monitor treatment safety and effectiveness within the institutional program.

Подробное описание

This clinical program supports the structured implementation and continuous development of stereotactic body radiotherapy (SBRT) for spinal metastases at the Institute of Oncology Ljubljana.

The program includes prospective peer review of target delineation and treatment plans, structured educational activities for involved staff, and continuous quality assurance procedures to maintain protocol adherence and treatment standardization. Retrospective review of previously delivered SBRT plans may be performed to evaluate consistency with institutional protocol standards.

All enrolled patients receive SBRT according to the institutional SBRT spine protocol. Clinical evaluation focuses on treatment-related toxicity assessed using standardized criteria and on radiological local tumor control during follow-up. Toxicity is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), and local control is assessed using routine radiological imaging.

All collected data are anonymized. Participation in the study does not involve additional interventions, procedures, or risks beyond standard SBRT treatment and routine clinical follow-up.

Вмешательства

  • Процедура Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases
    Participants with spinal tumors or spinal metastases receive image-guided stereotactic body radiotherapy (SBRT) delivered in 1-5 high-dose fractions according to the institutional SBRT spine protocol. The implementation programme includes standardized treatment planning procedures, protocol updates, immobilization techniques, image-guided verification (IGRT), and prospective peer review of target delineation and treatment plans to ensure quality and safety

Первичные конечные точки

  • Maximum Treatment-Related Adverse Event Grade Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Within 12 Months After Spine SBRT [Срок оценки: From start of SBRT treatment up to 12 months after SBRT]
Вторичные конечные точки (1)
  • Incidence of Grade 3 or Higher Treatment-Related Adverse Events Assessed by CTCAE Version 5.0 [Срок оценки: From start of SBRT treatment up to 12 months after SBRT]

Критерии участия

Критерии включения

  • Adult patients (≥18 years) with spinal metastases or spinal tumors referred for stereotactic body radiotherapy (SBRT).
  • Patients eligible for SBRT treatment according to the institutional SBRT spine protocol.
  • Ability to undergo CT simulation, immobilization, and image-guided radiotherapy procedures.

Критерии исключения

  • Inability to tolerate SBRT positioning or immobilization.
  • Clinical situations requiring urgent surgical intervention or alternative treatment.
  • Other medical conditions that prevent safe SBRT delivery.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Словения · 2 центра
  • Institute of Oncology — Ljubljana
  • Institute of Oncology Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07429422 · OI-SBRT-SPINAL-BUT-2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗