Lentigo Maligna Clinical Trial
— RADICALOfficial 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
Verified date | June 2024 |
Source | Melanoma and Skin Cancer Trials Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Melanoma and Skin Cancer Trials Limited | Melanoma Institute Australia |
Australia, Brazil, New Zealand,
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 |
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