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.
Phase 3
Active, not recruiting
- Conditions
- entigo maligna (LM)Lentigo maligna (LM)Cancer - Non melanoma skin cancer
- Registration Number
- ACTRN12615000266561
- Lead Sponsor
- Melanoma and Skin Cancer (MASC) Trials
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 126
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients experiencing LM treatment failure (biopsy) 6 months following completion of treatment[6 months after treatment completion]
- Secondary Outcome Measures
Name Time Method Proportion of patients experiencing LM treatment failure (dermoscopy) 12 and 24 months following treatment[12 and 24 months after treatment completion];Dermatology specific patient reported outcomes measured using Skindex questionnaire[Baseline, 4 weeks after starting imiquimod or 4 weeks post radiotherapy, then 3, 6, 12, 18 (optional) and 24 months];Cosmetic outcome 24 months after treatment or at treatment failure, assessed via photographs taken of the LM lesion(s)[24 months after treatment or at treatment failure];Difference in cumulative incidence of invasive melanoma within the treatment fields; a sub-study will evaluate the utility of reflectance confocal microscopy (RCM) compared with standard biopsy in diagnosing recurrence[0-24 months]