NCT05495399招募中不适用
Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Local control
研究概览
简要总结
To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
- •Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.
- •A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
- •Patients aged at least 20 years old are eligible.
- •Life expectancy of ≥ 6 months.
- •ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
- •No prior RT to the index spine level(s)
- •Women of childbearing potential must practice adequate contraception
- •Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.
排除标准
- •Patients received prior radiotherapy to the index spine level.
- •Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
- •Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
- •Patients who cannot tolerate radiotherapy immobilization.
- •Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
- •Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- •Transmural myocardial infarction ≤ 6 months prior to registration.
- •Life-threatening uncontrolled clinically significant cardiac arrhythmias.
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- •Uncontrolled psychiatric disorder.
- •Pregnant or breast-feeding women
研究组 & 干预措施
Spondylectomy with Conventional RT
Experimental
Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions
干预措施: Spondylectomy (Procedure)
Debulking surgery with Conventional RT
Active Comparator
Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions
干预措施: Spondylectomy (Procedure)
Debulking surgery with Conventional RT
Active Comparator
Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions
干预措施: SBRT (Radiation)
Debulking surgery with SBRT
Experimental
Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions
干预措施: SBRT (Radiation)
结局指标
主要结局
Local control
时间窗: 12 months post surgery
Number of patients with locally controlled disease of index spine after intervention
次要结局
- Quality of life assessment(Every 3 months up to 1 year post surgery)
- Treatment related toxicity(Every 3 months up to 1 year post surgery)
- Overall survival(12 months post surgery)
- pain control(Every 3 months up to 1 year post surgery)
- Quality of life assessment(pre surgery and 1 month after surgery)
研究者
研究点 (1)
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