NCT06330545

Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release

A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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

Detailed 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 days from CCH injection, or the need for medical/surgical intervention to correct the new or worsening contracture.

Conditions

• Dupuytren Contracture

Interventions

Type	Name	Description
RADIATION	Radiation 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.

Timeline

• Start date: 2024-09-16
• Primary completion: 2029-04-01
• Completion: 2032-04-01
• First posted: 2024-03-26
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States