Radiotherapy or Imiquimod in Complex Lentigo Maligna

Lentigo Maligna Clinical Trial

— RADICAL  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02394132
• Other study ID #: 02.12
• Status: Completed
• Phase: Phase 3
• Start date: August 31, 2015
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2024
• Source: Melanoma and Skin Cancer Trials Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 30, 2023
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

1. Aged 18 years or older.

2. A biopsy-proven LM. This includes previous treatment failures (not with imiquimod or RT) of LM that are diagnosed as biopsy-proven LM.

3. LM that is in a location amenable to treatment with imiquimod and radiotherapy.

4. Willing and able to comply with study requirements.

5. Written informed consent.

Exclusion Criteria:

1. Invasive melanoma.

2. Medical or psychiatric condition that compromises the ability of the patient to complete protocol treatment or follow-up assessments.

3. Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry.

4. Life expectancy of less than 2 years.

5. Radiotherapy sensitivity syndrome

Related Conditions & MeSH terms

• Lentigo
• Lentigo Maligna

Intervention

Drug:
• Imiquimod

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Melanoma Institute Australia	North Sydney	New South Wales
Australia	Skin and Cancer Foundation	Sydney	New South Wales
Australia	St Vincent's Hospital, Sydney	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
Brazil	Hospital das Clinicas, University of Sao Paulo	São Paulo
New Zealand	North Shore Hospital	Takapuna	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Melanoma and Skin Cancer Trials Limited	Melanoma Institute Australia

Countries where clinical trial is conducted

Australia,  Brazil,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing LM treatment failure	Determined by systematic biopsy, 6 months following completion of treatment.	6 months
Secondary	LM treatment failure at 12 months and 24 months after the completion of treatment.	Determined by dermoscopy and/or Reflectance Confocal Microscopy and confirmed by biopsy	12 and 24 months
Secondary	Quality of life using Skindex-16 questionnaire	Patient Reported outcomes were collected using the dermatology specific quality of life instrument Skindex-16 with additional questions specifically selected from the Skindex-29.; The Skindex-16 instrument covers three domains: Symptoms, 4 items; Function, 5 items; Emotions, 7 items. Standard scoring of domain scores uses the average of the component items, transformed to 0-100 scale, with higher scores indicating a greater negative impact of skin disease on quality of life (function, emotions) and greater symptom experience.	0-24 months
Secondary	Quality of life using Skindex-29 questionnaire	Due to the nature of this study it was decided to include additional questions from the Skindex-29 instrument (Q2, Q9 and Q18) as these questions address potential issues not covered by the Skindex-16.Similar to the Skindex-16, all responses are transformed to a linear scale of 100, with higher scores indicating more negative impact.	0-24 months
Secondary	Cosmetic outcome 24 months after treatment or at treatment failure	Evaluated using photographs taken of LM lesion(s) during the study	24 months
Secondary	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	Assessed at all time-points (6, 12 and 24 months post treatment). Time to failure of LM treatment and diagnosis with invasive melanoma within the treatment field was compared for each treatment arm using the log-rank test and Kaplan-Meier curves.	0-24 months