Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy - DEPART-trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54267

Enrollment

100

Registered

2023-06-29

Start date

2023-08-15

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's disease Viking disease

Interventions

30Gy in 10 fractions of split course Radiotherapy compared with Observation in both prevention and adjuvant settings. The time between the two courses is about 10 weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 (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

Exclusion criteria

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 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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
• Acute toxicity • Patient reported quality of life • Late toxicity	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)