A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Success rate for each strategy
研究概览
简要总结
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.
The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.
Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.
In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.
To date, no data from randomized study are available in the population of cancer patients.
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
- •Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
- •2 metastatic sites or more;
- •Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
- •Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
- •Pain equal or greater than 4/10 at Visual Analogic Scale
- •Unstable vertebrae (SINS score equal or greater than 7;
- •Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2
排除标准
- •Contraindication to vertebroplasty, including contraindication to cement use;
- •Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
- •Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
- •Neurological deficit due to medullar or radicular compression;
- •Participation to another clinical trial with an analgesic intent.
结局指标
主要结局
Success rate for each strategy
时间窗: 3 months after the procedure
The success rate will be calculated with the proportion of patients without cement leakage
次要结局
- Quality of Life in both arms at Day 21(21 days after procedure)
- Height of the targeted vertebrae(3 months after the procedure)
- Quality of Life in both arms at the end oh study(3 months after the procedure)
- Height of the patient(3 months after the procedure)
- Analgesic properties of the strategies at 21 days(21 days after the procedure)
- Size of cement leakage(3 months after the procedure)
- Symptoms associated with cement leakage(3 months after the procedure)
- Correlation between volume of cement injected and the level of pain relief using the Visual Analogic Scale(3 months after the procedure)
- Analgesic properties of the strategies at the end of the study(3 months after the procedure)
- Type of cement leakage (vascular versus cortical localisation)(3 months after the procedure)
- Tolerance profile of the strategies(Through study completion)
- Kyphotic angle(3 months after the procedure)
- Analgesic properties of the strategies the day after the procedure(The day after the procedure)