To hear about similar clinical trials, please enter your email below
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