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ANZMTG 02.12 RADICAL Trial - A randomised controlled multicentre trial of imiquimod versus radiotherapy for lentigo maligna (LM) when staged surgical excision with 5mm margins is not possible, is refused, or fails

To date, there have been no prospective studies or randomised controlled trials (RCT) conducted to form the basis of any  recommendations for the management of Lentigo Maligna (LM). LM is difficult to diagnose and to treat, which translates to high recurrence rates and high morbidity. Surgery by staged excision is recognised worldwide as the gold standard treatment as it provides a definitive pathology report that rules out the risk of invasive melanoma. Surgery may also result in major disfigurement to the face and neck. Medical treatments havebeen proposed to address these recurrences and cosmetic issues treating alarger field. Currently radiotherapy is recommended for the treatment of LM when surgical margins are inadequate or surgery is not possible, however only Level 3 evidence supports its use. Although Imiquimod use is becomingincreasingly common worldwide its efficacy has only been reported through case series.

In order to establish the optimum management for thesepatients and to accurately evaluate these treatments a prospective randomisedcontrolled clinical trial is required.

Study status - Current
ANZ Clinical Trials Registry # - ACTRN12615000266561 identifier - NCT02394132

Principal Investigator's details:

A/Prof Pascale Guitera
Melanoma Institute Australia

ANZMTG coordinator details:

PDF Downloads:

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