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Идёт набор NCT07478289

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

Фаза II С лечением Spine Metastasis

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: Radiation Boost.
Кому может быть актуально
Состояния в реестре: Spine Metastasis. 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
Канада
Следующий шаг
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Официальное название

OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)

Обзор

Spine SBRT is considered a standard of care for the treatment of spinal metastases. Compared to conventional radiation therapy, spine SBRT delivers high doses of radiation to the affected areas to the spinal metastases. This study is interested in seeing whether an additional 'boost' of radiation, delivered to the affected area in the spine, will result in better long-term control of the tumor; help reduce pain; and reduce long-term side effects of radiation therapy.

Вмешательства

  • Лучевая терапия Radiation Boost
    An additional boost of radiation will be delivered to the spinal metastases. The amount of boost depends on how much radiation would have been normally prescribed (e.g., if treatment required 2 fractions of radiation treatment, an additional 2 Gy would be prescribed; if treatment required 4 fractions of radiation treatment, an additional 4 Gy would be prescribed; if treatment required 5 fractions of radiation treatment, an additional 5 Gy would be prescribed).

Первичные конечные точки

  • Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines [Срок оценки: Up to 12 months after completion of radiation therapy]
Вторичные конечные точки (4)
  • Pain at treated spinal metastases, per ICPRE (International Consensus on Palliative Radiotherapy Endpoints) [Срок оценки: 3 and 6 months following completion of radiation therapy]
  • Type of progression [Срок оценки: Up to 12 months after completion of radiation therapy]
  • Treatment-related side effects as assessed by CTCAE v5.0 [Срок оценки: Up to 12 months following completion of radiation therapy]
  • Spinal Instability, as assessed through the Spinal Instability Neoplastic Scores (SINS) [Срок оценки: Up to 12 months following completion of radiation therapy]

Критерии участия

Критерии включения

  • Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
  • Spinal metastases with paraspinal disease extension documented with MRI and recommended for treatment with SBRT
  • Post-operative SBRT is permitted (after stabilization and/or decompression surgery) as long as no prior radiotherapy had been delivered to the spinal level planned for trial treatment and paraspinal disease is present
  • ECOG performance status 0-2
  • Able to tolerate protocol SBRT
  • Age 18 years or older
  • Patient is able and willing to complete the Patient Diary (pain and analgesic use)
  • Consent must be appropriately obtained in accordance with local requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be accessible for treatment and follow-up
  • Treatment to begin within 14 days (ideally 7 days) of radiotherapy simulation

Критерии исключения

  • Extremely radiosensitive histology (seminoma, small cell lung cancer, hematologic primaries)
  • Prior radiotherapy in the spine target of interest
  • Spinal instability as assessed by the Spinal Instability Neoplastic Score with a score of > 12
  • Symptomatic cord compression or cauda equine syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina, respectively. Symptomatic refers to neurologic deficit in the form of motor, bowel or bladder dysfunction
  • Pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely
  • Cytotoxic chemotherapy within 1 week prior to radiotherapy 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

Канада · 1 центр
  • Sunnybrook Health Sciences Centre — Toronto

Идентификаторы

NCT: NCT07478289 · OPTIMAL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗