Clinical Trial: Radiotherapy or Imiquimod in Complex Lentigo Maligna

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Controlled Multicentre Trial of Imiquimod Versus Radiotherapy for Lentigo Maligna (LM) When Staged Surgical Excision With 5mm Margins is Not Possible, is Refu

Brief Summary:

The purpose of this study is to investigate the effectiveness of using either radiotherapy (RT) or Imiquimod (ImiQ) to treat the Lentigo Maligna (LM), when surgery is not possible, is refused, or fails.

Surgery is the standard treatment for people diagnosed with LM. However for some people, it may not be possible due to the location of their LM lesion(s).

Currently, the Australian and New Zealand Melanoma Treatment Guidelines recommend radiotherapy for the treatment of LM however there is no clinical trial evidence for this and a trial is needed to prove which treatment is safer and more effective. Some clinicians may also recommend the use of a cream called Imiquimod. It is approved and widely used in Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts, and perianal warts. Although not currently licensed for treatment use in LM, there is some evidence to suggest that it is both safe and effective in treating LM.

This trial will scientifically evaluate and compare these two treatments in a controlled clinical setting.


Detailed Summary:
Sponsor: Australia and New Zealand Melanoma Trials Group

Current Primary Outcome: Proportion of patients experiencing LM treatment failure (as determined by systematic biopsy) 6 months following completion of treatment. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • LM treatment failure at 12 months and 24 months after the completion of treatment. [ Time Frame: 12 and 24 months ]
  • Quality of life using Skindex questionnaire [ Time Frame: 0-24 months ]
  • Cosmetic outcome 24 months after treatment or at treatment failure [ Time Frame: 24 months ]
    Evaluated using photographs taken of LM lesion(s) during the study
  • Incidence of invasive melanoma within treatment fields; a sub-study to evaluate the utility of reflectance confocal microscopy (RCM) compared with standard biopsy in diagnosing recurrence [ Time Frame: 0-24 months ]


Original Secondary Outcome: Same as current

Information By: Australia and New Zealand Melanoma Trials Group

Dates:
Date Received: March 10, 2015
Date Started: May 2015
Date Completion: November 2019
Last Updated: January 4, 2017
Last Verified: January 2017