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Q In patients with high risk malignant melanoma, is primary tumour excision with a surrounding margin of 3 cm more effective than a margin of 1 cm for reducing recurrence and improving survival?
Clinical impact ratings Dermatology ★★★★★★☆ Oncology ★★★★★★☆ Surgery ★★★★☆☆☆
METHODS
Design:
randomised controlled trial.
Allocation:
concealed.*
Blinding:
blinded (monitoring committee).*
Follow up period:
a median of 60 months.
Setting:
21 hospitals, 2 infirmaries, 1 cancer therapy network in the UK, and 1 cancer centre in Poland.
Patients:
900 patients >18 years of age (mean age 57 y, 52% men) who had a single primary localised cutaneous melanoma (⩾2 mm in thickness) on the trunk or limbs (excluding the palms of hands or the soles of the feet) where a 3 cm excision margin was technically possible. Exclusion criteria included pregnancy, a history of cancer (except basal cell carcinoma), and treatment with immunosuppressive agents.
Intervention:
primary …
Footnotes
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↵* See glossary.
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For correspondence: Mr J M Thomas, Royal Marsden Hospital National Health Service Trust, London, UK. Josephmeirion.thomasrmh.nthames.nhs.uk
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Sources of funding: 6 funding agencies.