NCT06173401招募中3 期
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients With Spinal Metastases (ALL-STAR)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Tumor control
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Single-fraction spine SRS
Experimental
Single-fraction spine SRS (22 Gy x 1)
干预措施: Single-fraction spine SRS (Radiation)
Multi-fraction spine SRS
Experimental
Multi-fraction spine SRS (14 Gy x 2)
干预措施: Multi-fraction spine SRS (Radiation)
结局指标
主要结局
Tumor control
时间窗: 1 year
To determine whether fractionated Stereotactic Radiosurgery (SRS) for spine metastases is associated with improved local tumor control at 1 year following SRS compared to single-fraction SRS.
次要结局
- Euro-QOL EQ-5D-3L health-related quality of life questionnaire(2 years)
- Pain Score(1-2 weeks after SRS and 1, 3, 6, 12, 18, and 24 months following SRS)
- Rate of vertebral compression fracture(1 year)
- European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 health-related quality of life scale score(2 years)
- Medication Intake(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(1 year)
- EORTC QLQ-BM22 health-related quality of life questionnaire(2 years)
- Rate of local failure(2 years)
研究者
研究点 (1)
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