Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Level of pain response 1 month after radiotherapy
研究概览
简要总结
In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Painful bone metastasis of solid tumors
- •Pain score minimum of 2 on a scale of 10
- •A maximum number of painful bone metastases: 3 or more
- •Life expectancy > 3 months
- •Age minimum 18 years old
- •Signed informed consent
排除标准
- •Tumor histology (renal cell and melanoma vs. other solid tumors)
- •VAS pain score (<5 vs. 6-10).
- •Bisphosphonate use (yes vs. no)
- •Opioid analgesics (yes vs. no)
- •Corticosteroid use (yes vs. no)
- •Spine vs non-spine localisation
研究组 & 干预措施
Biological image-guided SBRT with dose-escalation.
干预措施: Biological image-guided SBRT with dose-escalation. (Radiation)
Conventional radiotherapy
干预措施: Conventional Radiotherapy (Radiation)
Biological image-guided radiotherapy with conventional dose.
干预措施: Biological image-guided radiotherapy with conventional dose. (Radiation)
结局指标
主要结局
Level of pain response 1 month after radiotherapy
时间窗: 1 month after radiotherapy
Pain is measured with the visual analogue scale. Response is scored in accordance to the guidelines of the international consensus on palliative radiotherapy.
次要结局
- Quality of life 1 month after radiotherapy.(1 Month after radiotherapy)
