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Recruiting NCT06330545

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

No phase Interventional Dupuytren Contracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation therapy.
Who it may be relevant to
Registry conditions: Dupuytren Contracture. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Recurrence of Dupuytren's Contracture [Time frame: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment]
Secondary outcome measures (2)
  • Radiation Toxicity [Time frame: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment]
  • Patient Reported Outcomes after Radiation Treatment (RT) [Time frame: Before Radiation Treatment (RT), after completion of RT, 1-month post-RT, 6 months post-RT, 1 year post-RT, 2 years post-RT, and 3 years post-RT]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Dartmouth Hitchcock — Lebanon

Identifiers

NCT: NCT06330545 · STUDY02002161

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗