Dupuytren's Disease Evaluation of Preventative or Adjuvant Radiation Therapy: DEPART
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Number of Participants with Passive Extension Deficit (PED)
研究概览
简要总结
This is a randomized study to determine whether radiation therapy reduces the risk of progression / recurrence of Dupuytren's disease / contracture.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Patient consent
- •No previous radiotherapy to the affected hand
- •No history of radiation sensitivity diseases (e.g. Scleroderma, Ataxia Telangiectasia, Li Fraumeni)
- •Life expectancy >5 years
- •Available and willing to participate in at least 5 years of follow-up
- •Female patients capable of child-bearing that are not pregnant
排除标准
- •Pregnancy or lactation
- •Known genetic disease that would make them extremely sensitive to radiation therapy, e.g. Scleroderma, Ataxia Telangiectasia, Li Fraumeni
研究组 & 干预措施
Radiation Therapy
early stage DD (no flexion contraction in affected hand) - randomized to Radiotherapy
干预措施: Radiation Therapy (Radiation)
Standard of Care
Patients are receiving standard of care.
结局指标
主要结局
Number of Participants with Passive Extension Deficit (PED)
时间窗: Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months
Deterioration greater than 20 degrees Passive Extension Deficit (PED) in any joint(s) of any of the affected digit(s) from post-intervention baseline in the presence of a palpable cord OR instigation of salvage surgical fasciectomy (SF) or NA to any of the affected digit(s).
次要结局
- Number of participants with any adverse events of interest(Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months)
- Mean Pain Score(Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months)
- Total Score Unité Rhumatologique des Affections de la Main (URAM)(Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months)
- Total Score QuickDASH(Day 0 (corresponding to the day of local treatment for intervention groups) and then at 6, 12, 24, 36, 48, 60, 84 and 108 months)