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.

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000266561

Acronym

RADiotherapy or Imiquimod in Complex lentigo mALigna - RADICAL

Enrollment

126

Registered

2015-03-20

Start date

2015-08-31

Completion date

2021-02-24

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the effectiveness of using either radiotherapy or Imiquimod to treat lentigo maligna (LM), when surgery is not possible, is refused, or fails. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a biopsy proven LM. Study details: Surgery is the standard treatment for people diagnosed with LM. However for some people, it may not be possible due to the location of their LM lesion(s). Currently, the Australian and New Zealand Melanoma Treatment Guidelines recommend radiotherapy for the treatment of LM however there is no clinical trial evidence for this and a trial is needed to prove which treatment is safer and more effective. Some clinicians may also recommend the use of a cream called Imiquimod. Although not currently licensed for treatment use in LM, there is some evidence to suggest that it is both safe and effective in treating LM. Participants in this study will be randomly (by chance) allocated to either standard care radiotherapy or 12 weeks of treatment with imiquimod cream 5 times a week. All participants will be followed up to 24 months and attend regular visits with their study doctor to monitor side effects and treatment response.

Interventions

The trial will compare the efficacy of topical imiquimod 5% cream and radiotherapy to treat and prevent recurrences of LM in patients who are unable to have surgery, have refused surgery or have failed surgery. Arm 1: Topical imiquimod 5% cream - applied 5 days/week for a total of 12 weeks - dispensed at baseline visit - completion of patient diary

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results