Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease - A Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 10
- 主要终点
- local control rate (LC) at 1-year post SABR
研究概览
简要总结
This is a prospective, investigator-initiated, phase II, multicentre-study, investigating the efficacy and toxicity of definitive SABR of osseous oligometastases, when pragmatically introduced into a daily clinical setting.
详细描述
Patients with a histology or cytology proven non-hematological cancer and at least one lesion in the bones are eligible.
Patients with de novo- and induced oligometastatic disease, as well as patients with oligo-recurrence or oligo-progression disease can be included. A total of 67 patients will be enrolled.
The overall aim is to document long time follow-up in respect to local control rate, OS, PFS, rate of symptomatic skeletal event at the irradiated site(s), time to progression outside the radiation field at 1-, 2- and 5-years and acute/ late toxicities.
The primary endpoint is the rate of local control 1-year post SABR. Patients will have a CT scan and a clinical evaluation every 3 month after SABR according to the standard clinical follow-up program.
During the 1 year follow-up we also perform pain assessment (using the Numeric Pain Rating Scale), report the analgesic consumption and Quality of life (QoL) measured with EQ-5D-5L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histology or cytology proven non-haematological cancer.
- •At least one lesion in the bones is required.
- •ECOG performance status ≤
- •≥ 18 years old.
- •Life expectancy > 6 months.
- •GTV diameter ≤ 5 cm.
- •In case of de novo OMD and OMD recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed.
- •In case of OPD * and induced OMD*2 only 3 metastases (including the primary tumour) are allowed.
- •The metastatic lesion(s) must be visible on a CT- or MR- scan and suitable for treatment with SABR.
- •All metastatic sites are treated or planned for ablative therapy (including surgery) - for OPD only the sites in progression is required to fulfil this criterion. • A baseline scan within 28 days of inclusion (CT or PET- CT).
- •For spine/paraspinal targets, an MR scan is mandatory, if epidural growth cannot be precluded on the baseline CT scan.
- •No curative intended treatment option available.
- •An ablative strategy should be deemed clinically relevant and is at the discretion of the treating physician to decide.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patient cannot tolerate physical set up required for SABR.
- •Uncontrolled intercurrent illness.
- •Pregnancy.
- •Bilsky score ≥ 1b. If the patient is treated with surgery, a pre-operative Bilsky score ≥ 1b is an exclusion criterion as well. See appendix A for Bilsky score.
- •Presence of myelopathy from the target area.
- •Candidate for surgical treatment (determined by the institutions clinical oncologist, neurosurgeon or orthopaedic surgeon).
- •For spine/paraspinal lesions where epidural growth cannot be precluded on the baseline CT scan: patients for whom an MR scan is contraindicated.
- •Mechanical instability and/or fracture risk *
- •For spine disease, involvement of ≥ three contiguous vertebrae.
- •Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
- •Patients with uncontrolled brain metastases.
- •If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix B. -
结局指标
主要结局
local control rate (LC) at 1-year post SABR
时间窗: 1-year post SABR
Response evaluation is based on the interpretation of a experienced onco-radiologist and modifications from the MDACC response criteria's.
次要结局
- Pain, change from baseline evaluated by "Numeric Pain Rating Scale (NPRS)"(Measured at 2-, 12-, 24-, 36- and 52-weeks post SBRT)
- Local progression free survival(continuous within 2-years post SBRT)
- NCI CTCAE ≥ grade 3 toxicity(Measured at 2-, 12-weeks post SBRT)
- Rate of Symptomatic Skeletal Event (SSE) at the irradiated site(s)(3-, 6-, 12- and 24-months post SBRT)
- NCI CTCAE ≥ grade 3 late toxicity(Measured at 3-, 6-, 12- and 24-months post SBRT)
- Overall survival (OS)(continuous till 2-year post SABR)
- Progression-free survival (PFS)(Continuous and at 3-, 6-, 12- and 24-months post SBRT)
- Time to progression (TTP) outside the radiation field(Continuous and at 3-, 6-, 12- and 24-months post SBRT)
- Quality of life (QoL) measured with EQ-5D-5L.(at 3-, 6-, 12- and 24-months post SBRT)
研究者
Gitte Fredberg Persson MD PhD
Associate professor
Herlev Hospital