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Completed

NCT Number: NCT02394132

Radiotherapy or Imiquimod in Complex Lentigo Maligna

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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Key information

Conditions

Lentigo Maligna Hutchinson's Melanotic Freckle Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Calvary Mater Newcastle, Newcastle, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imiquimod

Drug

Other names: Aldara

Radiotherapy

Radiation

Primary outcomes

  1. Proportion of patients experiencing LM treatment failure

    Time frame: 6 months

    Determined by systematic biopsy, 6 months following completion of treatment.

Secondary outcomes

  1. LM treatment failure at 12 months and 24 months after the completion of treatment.

    Time frame: 12 and 24 months

    Determined by dermoscopy and/or Reflectance Confocal Microscopy and confirmed by biopsy

  2. Quality of life using Skindex-16 questionnaire

    Time frame: 0-24 months

    Patient Reported outcomes were collected using the dermatology specific quality of life instrument Skindex-16 with additional questions specifically selected from the Skindex-29.

    The Skindex-16 instrument covers three domains: Symptoms, 4 items; Function, 5 items; Emotions, 7 items. Standard scoring of domain scores uses the average of the component items, transformed to 0-100 scale, with higher scores indicating a greater negative impact of skin disease on quality of life (function, emotions) and greater symptom experience.

  3. Quality of life using Skindex-29 questionnaire

    Time frame: 0-24 months

    Due to the nature of this study it was decided to include additional questions from the Skindex-29 instrument (Q2, Q9 and Q18) as these questions address potential issues not covered by the Skindex-16.Similar to the Skindex-16, all responses are transformed to a linear scale of 100, with higher scores indicating more negative impact.

  4. Cosmetic outcome 24 months after treatment or at treatment failure

    Time frame: 24 months

    Evaluated using photographs taken of LM lesion(s) during the study

  5. Incidence of invasive melanoma within treatment fields; a sub-study to evaluate the utility of reflectance confocal microscopy (RCM) compared with standard biopsy in diagnosing recurrence

    Time frame: 0-24 months

    Assessed at all time-points (6, 12 and 24 months post treatment). Time to failure of LM treatment and diagnosis with invasive melanoma within the treatment field was compared for each treatment arm using the log-rank test and Kaplan-Meier curves.

Sponsors and collaborators

Lead sponsor

Melanoma and Skin Cancer Trials Limited

Other

Collaborators

  • Melanoma Institute Australia

Registry information

Official study title

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

Acronym: RADICAL

Important dates

Study start
2015
Primary completion
2021
Study completion
2023
First posted
Mar 20, 2015
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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