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Radiotherapy or Imiquimod in Complex Lentigo Maligna — RADICAL  

Lentigo Maligna Clinical Trial

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 Refused, or Fails

Clinical Trial 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.

Clinical Trial Description

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. The primary objective of this trial is to compare the rate of LM treatment failure and recurrence rate measured at 24 months (primary endpoint), and measured at 6, 12 months (secondary endpoints) following treatment with ImiQ or RT. For this study, treatment failure includes both the recurrence and persistence of LM, and is defined as the presence of LM cells within the original field of treatment confirmed by histopathology. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02394132
Study type Interventional
Source Melanoma and Skin Cancer Trials Limited
Contact
Status Completed
Phase Phase 3
Start date August 31, 2015
Completion date March 30, 2023
View Details
See also
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Completed NCT00707174 - Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna N/A
Completed NCT03508297 - Reflectance Confocal Microscopy to Diagnose MM & LM
Withdrawn NCT02306512 - Mohs and Immunofluorescence for Malignant Melanoma In Situ N/A
Completed NCT01161888 - Effect of Topical Imiquimod on Lentigo Maligna Phase 4
Completed NCT02723721 - Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face Phase 2
Terminated NCT04688749 - Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Active, not recruiting NCT01088737 - Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna Phase 2/Phase 3
Completed NCT02685592 - Photodynamic Therapy for Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion as a Light Sensitizing Cream Phase 4
Completed NCT00785369 - In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis N/A
Recruiting NCT06014619 - Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs