Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

Официальное название

A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)

Обзор

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.

Вмешательства

• Лучевая терапия Single-fraction spine SRS
  Treatment Arm 1: Single-fraction spine SRS (22 Gy x 1)
• Лучевая терапия Multi-fraction spine SRS
  Treatment Arm 2: Multi-fraction spine SRS (14 Gy x 2)

Первичные конечные точки

• Tumor control [Срок оценки: 1 year]

Вторичные конечные точки (8)

• Euro-QOL EQ-5D-3L health-related quality of life questionnaire [Срок оценки: 2 years]
• European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score [Срок оценки: 2 years]
• EORTC QLQ-BM22 health-related quality of life questionnaire [Срок оценки: 2 years]
• Pain Score [Срок оценки: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS]
• Medication Intake [Срок оценки: 1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS]
• Number of participants with CTCAE grade grade 2 or higher adverse effects [Срок оценки: 1 year]
• Rate of vertebral compression fracture [Срок оценки: 1 year]
• Rate of local failure [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
• Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
• Patients will have 1 to 3 separate spinal sites that require treatment.
• Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
• ECOG 0-2
• Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal
• people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
• Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document

Критерии исключения

• Prior or planned radiation off study within or overlapping with study treatment site
• Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
• Pediatric patients (age <18 years old), pregnant women, and nursing patients will be excluded
• Histology's of myeloma or lymphoma
• Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
• Prior surgery to spinal site intended to be treated with protocol SRS
• Excluded those with SINS 13-18

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

США · 1 центр

• Stanford University School of Medicine — Palo Alto

Идентификаторы

NCT: NCT06173401 · IRB-72248 · BRN0060 · NCI-2024-00695

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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