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临床试验/NCT01429493
NCT01429493已完成2 期

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

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.

Experimental

干预措施: Biological image-guided SBRT with dose-escalation. (Radiation)

Conventional radiotherapy

Active Comparator

干预措施: Conventional Radiotherapy (Radiation)

Biological image-guided radiotherapy with conventional dose.

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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