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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
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
Secondary ID [1] 0 0
02.12
Universal Trial Number (UTN)
Trial acronym
RADICAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lentigo Maligna 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients experiencing LM treatment failure
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
LM treatment failure at 12 months and 24 months after the completion of treatment.
Timepoint [1] 0 0
12 and 24 months
Secondary outcome [2] 0 0
Quality of life using Skindex-16 questionnaire
Timepoint [2] 0 0
0-24 months
Secondary outcome [3] 0 0
Quality of life using Skindex-29 questionnaire
Timepoint [3] 0 0
0-24 months
Secondary outcome [4] 0 0
Cosmetic outcome 24 months after treatment or at treatment failure
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 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
120 Years
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2023
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Skin and Cancer Foundation - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Sydney
Recruitment hospital [5] 0 0
St Vincent's Hospital, Sydney - Sydney
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
São Paulo
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melanoma Institute Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02394132
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pascale Guitera
Address 0 0
Melanoma Institute Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02394132