Radiotherapy or Imiquimod in Complex Lentigo Maligna

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australia and New Zealand Melanoma Trials Group; Melanoma and Skin Cancer Trials Limited
• Collaborator: Melanoma Institute Australia
• Treatments: Imiquimod

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