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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02394132
Registration number
NCT02394132
Ethics application status
Date submitted
10/03/2015
Date registered
20/03/2015
Date last updated
20/06/2024
Titles & IDs
Public title
Radiotherapy or Imiquimod in Complex Lentigo Maligna
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Scientific 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
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Secondary ID [1]
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02.12
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Universal Trial Number (UTN)
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Trial acronym
RADICAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lentigo Maligna
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: 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
Experimental: 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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of patients experiencing LM treatment failure
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Assessment method [1]
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Determined by systematic biopsy, 6 months following completion of treatment.
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Timepoint [1]
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6 months
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Secondary outcome [1]
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LM treatment failure at 12 months and 24 months after the completion of treatment.
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Assessment method [1]
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Determined by dermoscopy and/or Reflectance Confocal Microscopy and confirmed by biopsy
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Timepoint [1]
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12 and 24 months
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Secondary outcome [2]
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Quality of life using Skindex-16 questionnaire
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Assessment method [2]
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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.
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Timepoint [2]
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0-24 months
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Secondary outcome [3]
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Quality of life using Skindex-29 questionnaire
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Assessment method [3]
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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.
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Timepoint [3]
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0-24 months
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Secondary outcome [4]
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Cosmetic outcome 24 months after treatment or at treatment failure
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Assessment method [4]
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Evaluated using photographs taken of LM lesion(s) during the study
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Timepoint [4]
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24 months
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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0-24 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/03/2023
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Calvary Mater Newcastle - Newcastle
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Recruitment hospital [2]
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [3]
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Skin and Cancer Foundation - Sydney
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Recruitment hospital [4]
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Westmead Hospital - Sydney
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Recruitment hospital [5]
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St Vincent's Hospital, Sydney - Sydney
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Recruitment hospital [6]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [7]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2298 - Newcastle
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment postcode(s) [4]
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2145 - Sydney
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Recruitment postcode(s) [5]
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- Sydney
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Recruitment postcode(s) [6]
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4102 - Brisbane
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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São Paulo
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melanoma and Skin Cancer Trials Limited
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Melanoma Institute Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02394132
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pascale Guitera
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Address
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Melanoma Institute Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02394132
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