A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Recurrence of Dupuytren's Contracture
研究概览
简要总结
The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:
• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?
Participants will undergo:
- Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection
- Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy
详细描述
This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful Collagenase Clostridium Histolyticum (CCH) injection and release will receive a standardized regimen of adjuvant radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a > 20 degree worsening of contracture in the presence of a palpable cord as compared to within 14 days from CCH injection, or the need for medical/surgical intervention to correct the new or worsening contracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45 or greater with DC
- •Extension deficit >10 degrees
- •Unable to simultaneously place the affected finger and palm flat on a table.
- •Women included in the study will be post-menopausal or using contraception, and a pregnancy test will be performed as standard of care.
- •For patients who are having multiple CCH injections, only the first 2 joints on given hand will be included
排除标准
- •Unsuccessful non-surgical release (> N/1 disease)
- •They develop an open wound during CCH
- •Breast feeding or pregnancy
- •A chronic muscular, neurologic, or neuromuscular disorder affecting the hands.
- •Less than the age of 45
- •They have previously undergone radiation on the hand in which they plan to get CCH injections
- •They are pregnant women, impaired adults or prisoners
研究组 & 干预措施
Patients with Dupuytren's Contacture
Patients with Dupuytren's Contacture will undergo Collagenase Clostridium Histolyticum injection and release followed by two 5-day courses of radiation therapy separated by 6-8 weeks. They will then be followed for 3 years for recurrence.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Recurrence of Dupuytren's Contracture
时间窗: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Recurrence defined as \> 20 degrees worsening of contracture relative to within 14 days from CCH injection or the need for medical/surgical intervention to correct the new or worsening symptomatic contracture. The investigators will measure the contracture using the table top test in which patients their press hand with best of their ability. We will use a goniometer on dorsal surface of hand while performing table top test to measure PIP and MCP joints.
次要结局
- Radiation Toxicity(one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment)
- Patient Reported Outcomes after Radiation Treatment (RT)(Before Radiation Treatment (RT), after completion of RT, 1-month post-RT, 6 months post-RT, 1 year post-RT, 2 years post-RT, and 3 years post-RT)
研究者
Lance G. Warhold
Staff Physican, Principal Investigator
Dartmouth-Hitchcock Medical Center