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

NCT06330545 | Recruiting

• 1 other identifier: STUDY02002161
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dupuytren Contracture

Keywords

Dupuytren's contracture; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Recurrence of Dupuytren's Contracture

  Recurrence defined as \> 20 degrees worsening of contracture relative to within 14 days from CCH injection or the need for medical/surgical intervention to correct the new or worsening symptomatic contracture. The investigators will measure the contracture using the table top test in which patients their press hand with best of their ability. We will use a goniometer on dorsal surface of hand while performing table top test to measure PIP and MCP joints.

  one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment

Secondary Outcomes (2)

• Radiation Toxicity

  one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment

• Patient Reported Outcomes after Radiation Treatment (RT)

  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

Study Arms (1)

Patients with Dupuytren's Contacture

EXPERIMENTAL

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.

Radiation: Radiation therapy

Interventions

Radiation therapy 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.

Patients with Dupuytren's Contacture

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock

Lebanon, New Hampshire, 03766, United States

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lance Warhold, MD

  Dartmouth Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia S Schwarz, MD

CONTACT

603 650-5133; julia.s.schwarz@hitchcock.org

Lance Warhold, MD

CONTACT

603 650-5133

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physican, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2032
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

US (1)