Background
Phase III multicenter RCT. 129 patients with progressive early-stage Dupuytren's contracture (Tubiana N–N1). Randomized to RT (orthovoltage or electrons) vs observation alone. First randomized trial for RT in Dupuytren's disease. Co-conducted by the German Cooperative Group on Radiotherapy for Benign Diseases. Aimed to confirm efficacy of RT over natural history of early disease.
Interventions and follow up
Arm A: RT: 30 Gy total (5 × 3 Gy per series × 2 series, 12-week interval); orthovoltage 100–150 kV or electron beam
Arm B: Observation: watchful waiting without interventio
Primary endpoint: Disease stabilization (no progression) at 13 month
mFollow up: 13 month
Arm B: Observation: watchful waiting without interventio
Primary endpoint: Disease stabilization (no progression) at 13 month
mFollow up: 13 month
Results
Stabilization at 13 months (RT): 81% vs observation 23%, P<.001
Progression (nodule/cord growth): RT 19% vs observation 77%, P<.001
Symptom improvement (pain, skin tethering): Significantly better in RT arm
Progression (nodule/cord growth): RT 19% vs observation 77%, P<.001
Symptom improvement (pain, skin tethering): Significantly better in RT arm
Adverse events
Main adverse events: RT arm: mild acute erythema (grade 1) in 42%, pruritis 15%, dry desquamation 8%. No grade ≥3 acute toxicity. Late effects at 13 months: minimal — no fibrosis, no secondary malignancy, no functional change in hand dexterity.
Conclusions
RT significantly reduces disease progression in early-stage Dupuytren's compared to observation. At 13 months, 81% of RT patients had stable disease vs only 23% in the observation group. This is the first randomized evidence supporting RT as an effective intervention for early Dupuytren's contracture.
Key Limitations
Key Limitations: Short follow-up (13 months). Observation arm does not represent current best non-surgical care (collagenase clostridium histolyticum became available after this trial). Late progression in RT-stabilized patients beyond 2 years requires longer follow-up data. Sample size modest.
Clinical Context
This RCT, combined with long-term observational data, supports RT as the standard non-surgical treatment for early-stage (N–N1) progressive Dupuytren's contracture. German national guidelines recommend RT for early symptomatic Dupuytren's disease. In North America and UK, RT is less commonly used but gaining acceptance particularly at specialized centers.
References