CompletedPhase 3

Radiotherapy or Imiquimod in Complex Lentigo Maligna

Australia126 participantsStarted 2015-08-31

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Proportion of patients experiencing LM treatment failure

Timeframe: 6 months

Trial details

NCT IDNCT02394132

SponsorMelanoma and Skin Cancer Trials Limited

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-24

View on ClinicalTrials.gov More Lentigo Maligna trials