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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2032-04-30

Brief Summary

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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

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Detailed Description

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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

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Dupuytren Contracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Radiation therapy

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes