Lentigo Maligna
Conditions
Keywords
Lentigo maligna, Imiquimod, Radiotherapy
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.
Detailed 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.
Interventions
DRUGImiquimod
RADIATIONRadiotherapy
Sponsors
Melanoma Institute Australia
Melanoma and Skin Cancer Trials Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients experiencing LM treatment failure | 6 months | Determined by systematic biopsy, 6 months following completion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LM treatment failure at 12 months and 24 months after the completion of treatment. | 12 and 24 months | Determined by dermoscopy and/or Reflectance Confocal Microscopy and confirmed by biopsy |
| Quality of life using Skindex-16 questionnaire | 0-24 months | 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. |
| Quality of life using Skindex-29 questionnaire | 0-24 months | 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. |
| Cosmetic outcome 24 months after treatment or at treatment failure | 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 | 0-24 months | 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. |
Countries
Australia, Brazil, New Zealand
Outcome results
None listed