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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Toxicity | acute (30 days or less) and late (> 30 days) Grade 2 and Grade 3 toxicities from radiotherapy defined by Radiation Therapy Oncology Group | one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment |
| Patient Reported Outcomes after Radiation Treatment (RT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia S Schwarz, MD | Contact | 603 650-5133 | julia.s.schwarz@hitchcock.org | |
| Lance Warhold, MD | Contact | 603 650-5133 |
| Name | Affiliation | Role |
|---|---|---|
| Lance Warhold, MD | Dartmouth Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock | Recruiting | Lebanon | New Hampshire | 03766 | United States |
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| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 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.
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The investigators will also record hand function change from baseline to after therapy via the Brief Michigan Hand Questionnaire, a patient reported outcome measure. This questionnaire will be used before study enrollment, after completion of RT, one-month post-RT, six months post-RT, one year post-RT, two years post-RT, and three years post-RT. The Michigan Hand Questionnaire is scored from 0-100 with higher scores indicating better functioning and satisfaction. |
| 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 |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |