A Randomized, Pilot Study on tREatment VOLume De-escalation for SPINal mEtastases SBRT (REVOL-SPINE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2-years local progression-free survival
研究概览
简要总结
A single centre, non-profit, randomised, unblinded pilot study on volume definition for spinal stereotactic body radiation therapy treatment.
Randomization will be 1:1 between two types of SBRT treatment for spinal metastases. The statistical unit will be the individual vertebral metastasis. Multiple metastases will be randomized and evaluated independently.
详细描述
Patients with spinal oligometastases who will be evaluated for SBRT will have to sign informed consent before any study-related procedure. Afterwards, a simulation computed tomography (CT) will be performed, and the metastases will be randomized to:
- Control arm: volume definition according to Cox contouring guidelines
- Experimental arm: volume definition based on the pathological lesion at Magnetic Resonance Imaging (MRI).
The treatment will be delivered at the center in either three or five fractions.
The planned follow-up consists of routine visits and exams, as per common clinical practice, according to primary histology (including an MRI to evaluate response of the vertebral lesion treated) at 3 months, 6 months, and subsequently every 6 months until the 2-year follow-up period. During these visits, physicians will assess the adverse events and NRS (a unidimensional measure of pain intensity in adults, from 0 to 10, and the result will be compared to the baseline).
The gross tumor volume (GTV) will be defined by MRI and PET uptake, if available, and the simulation CT. The treatment volume will be delineated based on MRI coregistered with the planning CT. The MRI protocol will include T1, T2-weighted, and diffusion-weighted imaging (DWI) sequences. The Planning Target Volume (PTV) will be obtained by adding an isotropic margin of 2 mm from the GTV, avoiding the spinal canal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients affected by spinal metastases eligible for SBRT
- •All histologies are allowed
- •Oligometastatic disease (maximum 5 metastases) in every setting (oligopersistent, oligorecurrent and oligoprogressive, according to ESTRO consensus)
- •Metastases treated with ablative intent
- •Both symptomatic and asymptomatic vertebral metastases
- •Spine Instability Neoplastic Score (SINS) score < 7 [18]
- •Age > 18 years
- •Life expectancy > 12 months
- •PS ECOG 0-1
- •Vertebral pathological lesion on the diagnostic MRI
- •Single active lesion on the target vertebra
- •More lesions in different vertebrae can be simultaneously treated
- •Informed consent to trial participation and personal data treatment
排除标准
- •More than 2 adjoining vertebrae involved
- •Palliative intent
- •2 or more lesions on the target vertebra
- •Contraindications to MRI
- •More than 5 metastases
研究组 & 干预措施
Control Arm
volume definition of SBRT according to Cox contouring guidelines [Cox BW, International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery]
干预措施: Stereotactic Body Radiation Therapy (SBRT) in control arm (Radiation)
Experimental arm
volume definition of SBRT based on the pathological lesion at MRI delivered in three or five fractions
干预措施: Stereotactic Body Radiation Therapy (SBRT) in experimental arm (Radiation)
结局指标
主要结局
2-years local progression-free survival
时间窗: At 2 years from enrollment
Evaluation of the 2-years local progression-free survival (LPFS) of a different volume of SBRT for spinal treatment, targeted to the pathological lesion, evaluating the response after irradiation.
次要结局
- Local progression-free survival at 3, 6, 12 and 18 months(At 3, 6, 12 and 18 months from the enrollment)
- Adverse events; progression on a new vertebral segment; pain relief and pseudoprogression(At 3, 6, 12, 18 and 24 months from enrollment)