Trial Review

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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
Date results information initially provided
20/01/2022
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.
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.
Secondary ID [1] 286334 0
MASC 02.12
Universal Trial Number (UTN)
Trial acronym
RADiotherapy or Imiquimod in Complex lentigo mALigna - RADICAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lentigo maligna (LM) 294450 0
Condition category
Condition code
Cancer 294752 294752 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 291386 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 294512 0
Proportion of patients experiencing LM treatment failure (biopsy) 6 months following completion of treatment
Timepoint [1] 294512 0
6 months after treatment completion
Secondary outcome [1] 313526 0
Proportion of patients experiencing LM treatment failure (dermoscopy) 12 and 24 months following treatment
Timepoint [1] 313526 0
12 and 24 months after treatment completion
Secondary outcome [2] 313527 0
Dermatology specific patient reported outcomes measured using Skindex questionnaire
Timepoint [2] 313527 0
Baseline, 4 weeks after starting imiquimod or 4 weeks post radiotherapy, then 3, 6, 12, 18 (optional) and 24 months
Secondary outcome [3] 313528 0
Cosmetic outcome 24 months after treatment or at treatment failure, assessed via photographs taken of the LM lesion(s)
Timepoint [3] 313528 0
24 months after treatment or at treatment failure
Secondary outcome [4] 313529 0
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
Timepoint [4] 313529 0
0-24 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2015
Actual
31/08/2015
Date of last participant enrolment
Anticipated
Actual
24/02/2021
Date of last data collection
Anticipated
17/11/2022
Actual
Sample size
Target
266
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 3557 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment hospital [2] 7039 0
The Alfred - Prahran
Recruitment hospital [3] 7040 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 7041 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 7042 0
Westmead Hospital - Westmead
Recruitment hospital [6] 7043 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 7044 0
Skin and Cancer Foundation Australia (Westmead) - Westmead
Recruitment hospital [8] 9426 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [9] 12215 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 18136 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 24394 0
2050 - Camperdown
Recruitment postcode(s) [3] 9361 0
2060 - North Sydney
Recruitment postcode(s) [4] 14771 0
2145 - Westmead
Recruitment postcode(s) [5] 14772 0
2298 - Waratah
Recruitment postcode(s) [6] 9373 0
3004 - Melbourne
Recruitment postcode(s) [7] 9374 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 9375 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 7470 0
New Zealand
State/province [1] 7470 0
0622 - Auckland
Country [2] 10614 0
Brazil
State/province [2] 10614 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 290909 0
Government body
Name [1] 290909 0
Cancer Australia
Country [1] 290909 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Melanoma and Skin Cancer (MASC) Trials
Address
553 St Kilda Road
Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 289590 0
Other Collaborative groups
Name [1] 289590 0
Melanoma Institute Australia
Address [1] 289590 0
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country [1] 289590 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292510 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 292510 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 292510 0
Australia
Date submitted for ethics approval [1] 292510 0
26/11/2014
Approval date [1] 292510 0
15/06/2015
Ethics approval number [1] 292510 0
HREC/15/RPAH/13

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.
Trial website
https://www.masc.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55654 0
A/Prof Pascale Guitera
Address 55654 0
Melanoma Institute Australia
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 55654 0
Australia
Phone 55654 0
612 9911 7200
Fax 55654 0
Email 55654 0
pascale.guitera@melanoma.org.au
Contact person for public queries
Name 55655 0
Mr MASC Coordinator
Address 55655 0
553 St Kilda Road
Melbourne, Victoria 3004
Country 55655 0
Australia
Phone 55655 0
+613 9903 9022
Fax 55655 0
Email 55655 0
radical@masc.org.au
Contact person for scientific queries
Name 55656 0
Mr MASC Coordinator
Address 55656 0
553 St Kilda Road
Melbourne, Victoria 3004
Country 55656 0
Australia
Phone 55656 0
+613 9903 9022
Fax 55656 0
Email 55656 0
radical@masc.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.