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

02.12

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.

2015-08-31

2021-12-24

2023-03-30

Completed

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ACTUAL'}}

2024-06-17