Radiotherapy or Imiquimod in Complex Lentigo Maligna
- Registration Number
- NCT02394132
- Lead Sponsor
- Melanoma and Skin Cancer Trials Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- Aged 18 years or older.
- A biopsy-proven LM. This includes previous treatment failures (not with imiquimod or RT) of LM that are diagnosed as biopsy-proven LM.
- LM that is in a location amenable to treatment with imiquimod and radiotherapy.
- Willing and able to comply with study requirements.
- Written informed consent.
- Invasive melanoma.
- Medical or psychiatric condition that compromises the ability of the patient to complete protocol treatment or follow-up assessments.
- Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry.
- Life expectancy of less than 2 years.
- Radiotherapy sensitivity syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiotherapy Radiotherapy Radiotherapy * treatment regimen determined by treating radiation oncologist and as per standard practice at local institution * treatment to commence within 8 weeks of randomisation Imiquimod Imiquimod Topical imiquimod 5% cream * application to treatment area for 5 days/week for a total of 12 weeks * dispensed at baseline visit along with patient diary
- Primary Outcome Measures
Name Time Method Proportion of patients experiencing LM treatment failure 6 months Determined by systematic biopsy, 6 months following completion of treatment.
- Secondary Outcome Measures
Name Time Method 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.Cosmetic outcome 24 months after treatment or at treatment failure 24 months Evaluated using photographs taken of LM lesion(s) during the study
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-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.
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.
Trial Locations
- Locations (10)
North Shore Hospital
🇳🇿Takapuna, Auckland, New Zealand
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Skin and Cancer Foundation
🇦🇺Sydney, New South Wales, Australia
Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
St Vincent's Hospital, Sydney
🇦🇺Sydney, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Calvary Mater Newcastle
🇦🇺Newcastle, New South Wales, Australia
Melanoma Institute Australia
🇦🇺North Sydney, New South Wales, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Hospital das Clinicas, University of Sao Paulo
🇧🇷São Paulo, Brazil