Radiotherapy or Imiquimod in Complex Lentigo Maligna

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2023-03-30

Brief Summary

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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.

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Detailed Description

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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. It is approved and widely used in Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts, and perianal warts. 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.

This trial will scientifically evaluate and compare these two treatments in a controlled clinical setting.

The primary objective of this trial is to compare the rate of LM treatment failure and recurrence rate measured at 24 months (primary endpoint), and measured at 6, 12 months (secondary endpoints) following treatment with ImiQ or RT. For this study, treatment failure includes both the recurrence and persistence of LM, and is defined as the presence of LM cells within the original field of treatment confirmed by histopathology.

Conditions

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Lentigo Maligna

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imiquimod

Topical imiquimod 5% cream

* application to treatment area for 5 days/week for a total of 12 weeks
* dispensed at baseline visit along with patient diary

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

Radiotherapy

Radiotherapy

* treatment regimen determined by treating radiation oncologist and as per standard practice at local institution
* treatment to commence within 8 weeks of randomisation

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Interventions

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Imiquimod

Intervention Type DRUG

Radiotherapy

Intervention Type RADIATION

Other Intervention Names

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Aldara

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No