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Trial registered on ANZCTR
Registration number
ACTRN12615000266561
Ethics application status
Approved
Date submitted
10/03/2015
Date registered
20/03/2015
Date last updated
20/01/2022
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered
Titles & IDs
Public 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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Scientific title
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.
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Secondary ID [1]
286334
0
MASC 02.12
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Universal Trial Number (UTN)
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Trial acronym
RADiotherapy or Imiquimod in Complex lentigo mALigna - RADICAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lentigo maligna (LM)
294450
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Condition category
Condition code
Cancer
294752
294752
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0
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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
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Intervention code [1]
291386
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Treatment: Drugs
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Comparator / control treatment
Arm 2: Radiotherapy
- treatment regimen as per the treating radiation oncologist and standard procedures at the local institution
- treatment must commence within 8 weeks of randomisation
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of patients experiencing LM treatment failure (biopsy) 6 months following completion of treatment
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Assessment method [1]
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Timepoint [1]
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6 months after treatment completion
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Secondary outcome [1]
313526
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Proportion of patients experiencing LM treatment failure (dermoscopy) 12 and 24 months following treatment
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Assessment method [1]
313526
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Timepoint [1]
313526
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12 and 24 months after treatment completion
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Secondary outcome [2]
313527
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Dermatology specific patient reported outcomes measured using Skindex questionnaire
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Assessment method [2]
313527
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Timepoint [2]
313527
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Baseline, 4 weeks after starting imiquimod or 4 weeks post radiotherapy, then 3, 6, 12, 18 (optional) and 24 months
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Secondary outcome [3]
313528
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Cosmetic outcome 24 months after treatment or at treatment failure, assessed via photographs taken of the LM lesion(s)
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Assessment method [3]
313528
0
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Timepoint [3]
313528
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24 months after treatment or at treatment failure
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Secondary outcome [4]
313529
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Difference in cumulative incidence of invasive melanoma within the treatment fields; a sub-study will evaluate the utility of reflectance confocal microscopy (RCM) compared with standard biopsy in diagnosing recurrence
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Assessment method [4]
313529
0
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Timepoint [4]
313529
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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
No limit
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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)
Allocation of treatment will be performed centrally via an online randomisation system. Sites will be notified as to which arm treatment the patient was allocated via email.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in a 1:1 ratio.
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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
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/05/2015
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Actual
31/08/2015
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Date of last participant enrolment
Anticipated
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Actual
24/02/2021
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Date of last data collection
Anticipated
17/11/2022
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Actual
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Sample size
Target
266
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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]
3557
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The Poche Centre, Melanoma Institute Australia - North Sydney
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Recruitment hospital [2]
7039
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The Alfred - Prahran
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Recruitment hospital [3]
7040
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
7041
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [5]
7042
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Westmead Hospital - Westmead
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Recruitment hospital [6]
7043
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [7]
7044
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Skin and Cancer Foundation Australia (Westmead) - Westmead
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Recruitment hospital [8]
9426
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [9]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
18136
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
24394
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2050 - Camperdown
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Recruitment postcode(s) [3]
9361
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2060 - North Sydney
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Recruitment postcode(s) [4]
14771
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2145 - Westmead
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Recruitment postcode(s) [5]
14772
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2298 - Waratah
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Recruitment postcode(s) [6]
9373
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3004 - Melbourne
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Recruitment postcode(s) [7]
9374
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
9375
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
7470
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New Zealand
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State/province [1]
7470
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0622 - Auckland
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Country [2]
10614
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Brazil
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State/province [2]
10614
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Sao Paulo
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Funding & Sponsors
Funding source category [1]
290909
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Government body
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Name [1]
290909
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Cancer Australia
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Address [1]
290909
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Level 14, 300 Elizabeth Street, Surry Hills NSW 2010
Locked Bag 3, Strawberry Hills NSW 2012
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Country [1]
290909
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Melanoma and Skin Cancer (MASC) Trials
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Address
553 St Kilda Road
Melbourne, Victoria 3004
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Country
Australia
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Secondary sponsor category [1]
289590
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Other Collaborative groups
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Name [1]
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Melanoma Institute Australia
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Address [1]
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The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
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Country [1]
289590
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
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Research Development Office Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/11/2014
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Approval date [1]
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15/06/2015
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Ethics approval number [1]
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HREC/15/RPAH/13
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Summary
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.
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Trial website
https://www.masc.org.au/
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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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A/Prof Pascale Guitera
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Address
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Melanoma Institute Australia
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
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Country
55654
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Australia
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Phone
55654
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612 9911 7200
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Fax
55654
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Email
55654
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pascale.guitera@melanoma.org.au
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Contact person for public queries
Name
55655
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MASC Coordinator
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Address
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553 St Kilda Road
Melbourne, Victoria 3004
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Country
55655
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Australia
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Phone
55655
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+613 9903 9022
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Fax
55655
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Email
55655
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radical@masc.org.au
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Contact person for scientific queries
Name
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MASC Coordinator
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Address
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553 St Kilda Road
Melbourne, Victoria 3004
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Country
55656
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Australia
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Phone
55656
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+613 9903 9022
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Fax
55656
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Email
55656
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radical@masc.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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