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

NCT ID: NCT06330545

Condition: Dupuytren Contracture

Conditions: Official terms:
Dupuytren Contracture
Contracture

Conditions: Keywords:
Dupuytren's contracture
radiation therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful CCH injection and release will receive a standardized regimen of 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, or the need for medical/surgical intervention to correct the new or worsening contracture.

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Radiation therapy
Description: 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.
Arm group label: Patients with Dupuytren's Contacture

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.

Criteria for eligibility:
Criteria:
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 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

Gender: All

Minimum age: 45 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Dartmouth Hitchcock

Address:
City: Lebanon
Zip: 03766
Country: United States

Status: Recruiting

Contact:
Last name: Julia Schwarz, MD

Phone: 603-650-5133
Email: julia.s.schwarz@hitchcock.org

Start date: October 2024

Completion date: April 2032

Lead sponsor:
Agency: Dartmouth-Hitchcock Medical Center
Agency class: Other

Source: Dartmouth-Hitchcock Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06330545

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