Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
研究概览
简要总结
To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy.
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
- •Personally signed and dated written informed consent,
- •Histological diagnosis of malignancy,
- •Histologically or radiologically diagnosed bone metastasis,
- •Age ≥ 18 years
- •Pain or under pain control medication
排除标准
- •Pregnant or lactating women,
- •Women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment,
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.,
- •Prior radiotherapy to the intended treatment site,
- •Lesions > 5cm in maximum diameter,
- •Prior treatment with radioactive isotopes within 30 days of randomisation,
- •Spinal column, hands, feet, or head as intended treatment site,- Fracture at the intended treatment site,
- •Surgery required or previous surgery at the intended treatment site
- •Instability of the intended treatment site.
研究组 & 干预措施
SBRT with 9 Gy x 3 fractions to the treatment site.
Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.
干预措施: SBRT (Radiation)
SBRT with 7 Gy x 5 fractions to the treatment site
Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.
干预措施: SBRT (Radiation)
结局指标
主要结局
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
时间窗: Baseline and 3 months after treatment
The Visual Analog Scale is a validated, subjective measure for pain. Possible scores ranges between zero (no pain) and ten (worst possible pain). The primary endpoint was defined as pain relief \> 2 points from Baseline to 3 months after treatment.
次要结局
未报告次要终点