Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Phase 3

Recruiting

Conditions: Dupuytren's disease
10010761
Viking disease

Registration Number: NL-OMON54267

Lead Sponsor: GenesisCare Cancer Care Research Pty Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Prevention cohort
• Evidence of nodules and/or cords in the affected hand consistent with DD
• History of progressive DD over previous 6 months
• No previous radiotherapy to the affected hand
• No history of radiation sensitivity diseases (eg Scleroderma, Ataxia
Telangiectasia, Li Fraumeni)
• No previous SF, NA or CI in the affected hand
• Absence of flexion contractures: Passive extension deficit (PED) must be less
than, or equal to, 10 degrees (<=10°) in any joints of the affected hand.
• Age>30
• Patient Consent

Adjuvant cohort
• Local treatment with Needle Aponeurotomy (NA) of flexion contracture(s)
performed within 6-12 weeks prior to post-intervention baseline measurements
• Age>30
• No previous radiotherapy to the affected hand
• No history of radiation sensitivity diseases (eg Scleroderma, Ataxia
Telangiectasia, Li Fraumeni)
• Lack of major acute complications due to surgical intervention and <=20
degrees PED in each joint of treated ray
• Able to commence radiotherapy treatment within 12 weeks of local treatment
with Needle Aponeurotomy (NA).
• Patient consent

Exclusion Criteria

Prevention cohort
• No evidence of nodules and/or cords in the affected hand consistent with DD
• No history of progressive DD over previous 6 months
• Previous radiotherapy to the affected hand
• History of radiation sensitivity diseases (eg Scleroderma, Ataxia
Telangiectasia, Li Fraumeni)
• Previous SF, NA or CI in the affected hand
• Prescence of flexion contractures: Passive flexion contracture greater than
10 degrees (>10°) in all joints of the affected hand.
• Age <= 30
• No patient Consent

Adjuvant cohorts
• Local treatment with Needle Aponeurotomy (NA) of flexion contracture(s) is
not performed within 6-12 weeks prior to post-intervention baseline measurements
• Age<=30
• Previous radiotherapy to the affected hand
• History of radiation sensitivity diseases (eg Scleroderma, Ataxia
Telangiectasia, Li Fraumeni)
• Major acute complications due to surgical intervention and >20 degrees PED in
each joint of treated ray
• Not able to commence radiotherapy treatment within 12 weeks of local
treatment with Needle Aponeurotomy (NA).
• No patient consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To show a meaningful reduction in progression of DD with the application of<br /><br>radiotherapy both in the early stages as well as following local treatment in<br /><br>the later stages.<br /><br><br /><br>Primary Endpoint is Disease Progression, defined as:<br /><br>- Prevention Group: Measurement of 20 degrees, or greater, PED in joint(s) of<br /><br>an affected hand OR instigation of salvage SF or NA to the affected hand or<br /><br>- Adjuvant Group: Deterioration greater than 20 degrees PED in any joint(s) of<br /><br>any of the affected digit(s) from post-intervention baseline in the presence of<br /><br>a palpable cord OR instigation of salvage SF or NA to any of the affected<br /><br>digit(s). </p><br>

Secondary Outcome Measures