NCT02394132

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_3

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

August 31, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

6.3 years

First QC Date

March 10, 2015

Last Update Submit

June 17, 2024

Conditions

Lentigo Maligna

Keywords

Lentigo malignaImiquimodRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients experiencing LM treatment failure

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

    6 months

Secondary Outcomes (5)

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

    12 and 24 months

  • Quality of life using Skindex-16 questionnaire

    0-24 months

  • Quality of life using Skindex-29 questionnaire

    0-24 months

  • Cosmetic outcome 24 months after treatment or at treatment failure

    24 months

  • 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

    0-24 months

Study Arms (2)

Imiquimod

EXPERIMENTAL

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

Drug: Imiquimod

Radiotherapy

EXPERIMENTAL

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

Radiation: Radiotherapy

Interventions

ImiquimodDRUG
Also known as: Aldara
Imiquimod
RadiotherapyRADIATION
Radiotherapy

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Melanoma Institute Australia

North Sydney, New South Wales, 2060, Australia

Location

Skin and Cancer Foundation

Sydney, New South Wales, 2010, Australia

Location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

St Vincent's Hospital, Sydney

Sydney, New South Wales, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Hospital das Clinicas, University of Sao Paulo

São Paulo, Brazil

Location

North Shore Hospital

Takapuna, Auckland, 0740, New Zealand

Location

MeSH Terms

Conditions

Hutchinson's Melanotic Freckle

Interventions

ImiquimodRadiotherapy

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and Melanomas

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Pascale Guitera

    Melanoma Institute Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 20, 2015

Study Start

August 31, 2015

Primary Completion

December 24, 2021

Study Completion

March 30, 2023

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

BR(1)AU(8)NZ(1)