A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release
Dartmouth-Hitchcock Medical Center
Summary
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
Description
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…
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * Unsuccessful non-surgical release (\> N/1 disease) * They develop an open wound during CCH * Breast feeding or pregnancy * A chronic muscular, neurologic, or neuromusc…
Interventions
- RadiationRadiation therapy
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.
Location
- Dartmouth HitchcockLebanon, New Hampshire