Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
This is a randomised phase III trial which is being performed on patients at high risk of
local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is
surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus
post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose
administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever
performed. The target is 230 patients.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Locoregional control
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
No
Bryan Burmeister
Study Chair
Princess Alexandra Hospital
Australia: Human Research Ethics Committee
TROG 02.01
NCT00287196
March 2002
December 2011
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