Image-guided and Intensity-modulated Radiotherapy Versus External Beam Radiotherapy for Patients With Spine Metastases
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- quality of life
研究概览
简要总结
The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each.
Experimental intervention:
IMRT 10 x 3 Gy
Control intervention:
3D-RT 10 x 3 Gy
详细描述
The aim of this explorative trial is to verify the comparability of a fractionated intensity modulated radiotherapy with a conventional radiotherapy related to quality of life on the one hand and to evaluate toxicity, re-calcification and stability of vertebral body as well as pain relief and local response for palliative patients with painful spinal bone metastases on the other hand. This is a single-center, prospective randomized controlled trial with parallel-group design to determine the quality of life after RT in patients with spinal bone metastases. Two different techniques were evaluated: intensity modulated radiotherapy (IMRT) and fractionated conventional external beam RT with 10×3 Gy each.
Experimental intervention:
IMRT 10 x 3 Gy
Control intervention:
3D-RT 10 x 3 Gy After the baseline measurements have been recorded, the patients will be randomly assigned to one of the two groups: IMRT 10×3 Gy (n = 30) or fractionated conventional 3D-RT 10×3 Gy (n = 30). The RT will be applied daily (mondy to Friday).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologically confirmed tumor diagnosis and with secondary diagnosed solitary/multiple spinal bone metastases
- •Indication for RT of the spinal bone metastases
- •Age of between 18 and 85 years
- •Karnofsky index of at least 50
- •Signed declaration of informed consent
排除标准
- •Significant neurological or psychiatric disorders, including dementia and epileptic seizures
- •Previous RT at the current irradiation site
- •Other severe disorders that in the judgment of the study director may prevent the patient's participation in the study
- •Lacking or diminished legal capacity
- •Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately understand the scope of the study and to give his or her consent.
研究组 & 干预措施
A
intensity modulated radiotherapy (IMRT) 10 x 3 Gy
干预措施: IMRT (Radiation)
B
fractionated conventional external beam RT 10×3 Gy
干预措施: fractionated RT (Radiation)
结局指标
主要结局
quality of life
时间窗: 3-months-time-point after the end of RT
improvement of more than 10% according to the EORTC BM22 questionaire measured at the 3-months-time-point after the end of RT (t2).
次要结局
- bone density(12 weeks post completion radiotherapy)
- pain reduction(end of treatment, 12 and 24 weeks post completion of radiotherapy)
- Fatigue(12 and 24 weeks post completion of therapy)