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

Dartmouth Health

Status: Enrolling

Conditions: Dupuytren Contracture

Treatments: Radiation: Radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06330545

STUDY02002161

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Patients with Dupuytren's Contacture

Experimental group

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.

Treatment:

Radiation: Radiation therapy