ANZMTG 02.12 RADICAL
Research type
Research Study
Full title
Radiotherapy or Imiquimod in Complex Lentigo Maligna, The RADICAL trial (ANZMTG 02.12). 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.
IRAS ID
239584
Contact name
Elizabeth Paton
Contact email
Eudract number
2018-003138-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Australia and New Zealand Clinical Trials Registry, ACTRN12615000266561
Duration of Study in the UK
4 years, 9 months, 2 days
Research summary
The RADICAL Trial is designed to compare Radiotherapy (RT) and Imiquimod cream (ImiQ) for patients with complex lentigo maligna (LM). The clinical practice guidelines for the management of Melanoma in the UK recommends RT for patients with LM if surgery is not possible and ImiQ may be used but the level of evidence for either is low and practice varies around the world.
Patients, 18 years or older with biopsy proven lentigo maligna who are unable to undergo, refused or have failed surgery will be eligible for the trial
This is a multi-centre, randomised controlled phase III trial, recruiting patients internationally at hospitals in Australia, New Zealand and the UK
The study will consist of;
1. Enrolment and screening period to evaluate the LM diagnosis and area to treat
2. Treatment with Radiotherapy or Imiquimod
3. Follow-up. Dermoscopy, histopathology, and quality of life assessments are performed at various intervals up to the 24 month post treatment visit
The primary endpoint is the proportion of patients experiencing LM treatment failure at 6 months post treatment completion. Various secondary endpoints will also be analysed comparing the treatments including, LM treatment failure at 12 and 24 months, cumulative incidence of invasive melanoma, patient reported quality of life outcomes, cosmetic outcome, health care cost to identify which therapy is more cost effective, and the utility of reflectance confocal microscopy.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0032
Date of REC Opinion
16 Apr 2019
REC opinion
Further Information Favourable Opinion