Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease

Обзор

This study evaluates a new radiation treatment approach for patients with cancer that has spread to the spine (vertebral metastases) and involves limited extension around the spinal cord without causing compression (non-compressive epiduritis). This condition is common and can lead to serious complications, including pain and spinal cord compression, potentially affecting mobility and quality of life. The current standard of care is conventional radiotherapy, which is effective for symptom relief but may provide limited long-term tumor control. As advances in cancer treatments have improved survival, there is an increasing need for treatment approaches that better prevent local tumor progression in the spine. This randomized clinical trial compares standard radiotherapy with stereotactic radiotherapy (SRT), an advanced and highly precise radiation technique that delivers higher doses directly to the tumor while minimizing exposure to surrounding healthy tissues, including the spinal cord. The primary objective is to determine whether SRT can improve local disease control while maintaining an acceptable safety profile. The study will evaluate the proportion of patients who are alive without spinal disease progression (including spinal cord compression or local tumor recurrence) at one year after treatment. Secondary outcomes include treatment-related side effects, time to disease progression, overall survival, quality of life, feasibility of delivering SRT within a defined timeframe, risk of vertebral fractures, and need for additional radiation treatment. Eligible patients will have an estimated life expectancy greater than six months. Strict radiation dose constraints will be applied to minimize the risk of spinal cord injury, and patient safety will be closely monitored, including implementation of an early stopping rule in case of unexpected severe toxicity. The hypothesis of the study is that stereotactic radiotherapy will improve local control of spinal metastases compared with standard radiotherapy, without increasing the risk of serious adverse effects.

Вмешательства

• Лучевая терапия Stereotactic Body Radiotherapy (SBRT)
  Stereotactic body radiotherapy delivered in 5 fractions, consisting of 20 Gy to the involved vertebra and spinal canal (including adjacent hemi-vertebrae) with a simultaneous integrated boost to 35 Gy in 5 fractions to the tumor volume, according to protocol-defined delineation and dose constraints.
• Лучевая терапия Conventional External Beam Radiotherapy
  Conventional external beam radiotherapy delivered in 5 fractions with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent hemi-vertebrae, in accordance with standard palliative practice.

Первичные конечные точки

• 1-year Clinical Disease Control Rate [Срок оценки: 12 months after randomization]

Критерии участия

Критерии включения

• Histologically confirmed solid tumor;
• Vertebral bone metastasis located between C2 and S1 (inclusive) with epiduritis (spinal cord or cauda equina) without clinical and/or radiological spinal cord compression on MRI;
• Performance status (PS) ≤ 1;
• Spinal Instability Neoplastic Score (SINS) ≤12;
• Patient has been informed and has provided freely given, written, and signed informed consent;
• Patient is affiliated with or a beneficiary of the national health insurance system.

Критерии исключения

• Neurological deficit attributable to spinal cord compression or cauda equina syndrome;
• Patient experiencing pain that prevents lying down for 30 minutes despite optimal analgesic treatment;
• Life expectancy ≤6 months as estimated by the investigator;
• Neurosurgical indication (preventive or decompressive) prior to radiotherapy;
• More than one epiduritis lesion requiring treatment;
• Prior surgery on the same vertebra targeted in the protocol;
• Epiduritis and/or bone lesion extending over more than three contiguous vertebral levels;
• Previous irradiation of the spine with cumulative dose with cumulative spinal cord dose EQD2 >50 Gy, α/β = 2;
• Contraindication to MRI;
• Pregnant or breastfeeding woman;
• Patient under legal protection, guardianship, or unable to provide informed consent;
• Inability to comply with study follow-up due to geographic, social, or psychological reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 14 центров

• Institut de Cancerologie de L'Ouest — Angers
• CLCC Ste Catherine - Institut du cancer Avignon/Provence — Avignon
• Chu de Brest — Brest
• CHD Vendée — La Roche-sur-Yon
• Centre Gillaume le Conquérant — Le Havre
• Clinique Victor Hugo — Le Mans
• Groupe Hospitalier Bretagne Sud (GHBS) — Lorient
• Institut de Cancérologie Radiothérapie Bretillien (ICRB) — Rennes
• … и ещё 6 центров

Идентификаторы

NCT: NCT07656883 · ICO-2024-27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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