This trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Locoregional control
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Disease-free survival
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Overall survival
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Toxicity
Time frame: Interim analysis will occur on annual basis.
Quality of life
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
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