Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

Обзор

The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) in the treatment of patients undergoing surgery for spinal metastases. The main questions this study aims to answer are: * Does preoperative SBRT result in local tumor control at the involved spinal segments as assessed by MRI/CT scan at 3 and 6 months postoperatively? * What are the postoperative outcomes in terms of pain intensity, functional status and quality of life? Participants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention. Participants will undergo preoperative and follow-up assessments, including: * MRI and CT scans before and after surgery and at 3 and 6 months after surgery to measure tumor size * Pain questionnaires where patients rate their current pain, worst pain, and average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable) * A short questionnaire (Karnofsky Performance Status) to assess the patient's general ability to carry out daily activities * Several patient questionnaires to evaluate back pain, physical limitations, and overall quality of life (Oswestry Disability Index, EORTC QLQ-C30, and EORTC QLQ-BM22)

Вмешательства

• Лучевая терапия Preoperative Stereotactic Body Radiotherapy (SBRT)
  Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines.
• Процедура Spinal Surgery for Decompression and/or Stabilization
  Surgical intervention is performed following SBRT, based on clinical indication. It includes decompression of the spinal canal in cases of spinal cord or nerve compression (via laminectomy and/or foraminotomy), and/or dorsal instrumentation for unstable spines using pedicle screws guided by a neuronavigation system (Brainlab, Munich, Germany)

Первичные конечные точки

• Local Tumor Control [Срок оценки: 3 months after treatment]

Вторичные конечные точки (7)

• Local Tumor Control [Срок оценки: 6 months after treatment]
• Pain relief [Срок оценки: at discharge from initial hospitalization (typically within 5-10 days after surgery), 3 and 6 months after treatment]
• Wound Healing Complications at Hospital Discharge [Срок оценки: at discharge from initial hospitalization (typically within 5-10 days after surgery)]
• EORTC QLQ-C30 Scores [Срок оценки: 3 and 6 months after treatment]
• EORTC QLQ-BM22 Scores [Срок оценки: 3 and 6 months after treatment]
• Oswestry Disability Index (ODI) [Срок оценки: 3 and 6 months after treatment]
• Number of participants with radiologically confirmed instrumentation failure [Срок оценки: 6 months after surgery]

Критерии участия

Критерии включения

• Indication for surgical treatment of a spinal tumor
• Age: older or 18 years
• Estimated survival > 6 months
• The patient is able to understand the nature, significance and scope of the clinical study in the context of patient information and to base the decision to participate in the study on this.

Критерии исключения

• Age: < 18 years
• Motor deficit or loss of bladder and bowel control that urges an emergency surgical decompression
• Tumor extent does not allow hypofractioned SBRT (1-3 fractions)

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

Германия · 1 центр

• University Medical Center Goettingen — Göttingen

Идентификаторы

NCT: NCT07135817 · 14/5/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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