Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Dupuytren*s Disease (DD) is a genetic disorder of the myofibroblasts
characterised by the deposition of collagen within the fascia of the hands
which can eventually lead to the development of flexion contractures. No
intervention has been definitively shown to reduce the likelihood of disease
progression.Low dose radiotherapy has a long history of being deployed prior to
development of significant contractures with the intention of preventing
disease progression.Most of the data suggests that the risks of radiotherapy
are low, and that only a minority of patients who receive such treatment will
progress with long term follow-up. Some influental recent reviews however
conclude that the evidence base to justify radiotherapy as a standard treatment
option is poor. Conversely, more advanced DD has a range of interventions
available with the aim of reducing flexion contractures and improving
dexterity. Three main approaches are used:
1. Surgical Fasciectomy (SF)
2. Needle Aponeurotomy (NA)
A comprehensive understanding of the toxicities of radiotherapy in the
management of DD has not been well reported due to firstly the preponderance of
single institution, largely retrospectively acquired data, but also that much
of this is physician assessed rather than patient reported. As such, an
important part of this study would be to prospectively collect both physician
and patient reported outcomes (PROs).

Primary objective:
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.

Secondary objectives:
1. Report physician graded toxicity for radiotherapy.
2. Compare patient reported pain and functional outcomes via validated tools
for radiotherapy versus observation between arms at 1, 3, 5, 7 and 9 years, as
well as within arms between baseline and 9 years, or at progression, whichever
arrives first.

An international, multicenter, randomized controlled clinical phase III trial -
Observation (standard of care) v Radiotherapy (experimental arm)

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.

Study load:
Patients randomized to receive radiotherapy treatment must come to the hospital
daily for 2 weeks for radiation treatment. In addition, the inspections in the
context of the research are more frequent than is currently applied in clinical
practice.

Risk:
Very low risk of radiation-induced skin cancer (estimated at <0.1% for life)

Justification:
With this study, the effectiveness of radiotherapy as a treatment method for
Dupuytren's disease can be proven. In case of a positive effect of the
radiotherapy treatment, an advantage for the patient, treated with
radiotherapy, may be that there is an improvement of the complaints (including
pain, irritation / itching, curvature, size of the nodules and / or strands) as
a result. of Dupuytren's disease.
The chance of developing a radiation-induced malignancy is very low.