ACTRN12615000266561
Active, not recruiting
Phase 3
A randomised controlled multicentre trial to evaluate the effect of imiquimod versus radiotherapy on treatment failure at 6 months in patients with lentigo maligna (LM) for which staged surgical excision with 5mm margins is not possible, is refused, or fails.
Melanoma and Skin Cancer (MASC) Trials0 sites126 target enrollmentMarch 20, 2015
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- entigo maligna (LM)
- Sponsor
- Melanoma and Skin Cancer (MASC) Trials
- Enrollment
- 126
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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