Lentigo MalignaPhase 3RADICALNCT02394132
Radiotherapy or Imiquimod in Complex Lentigo Maligna
A Phase 3 study testing Imiquimod and Radiotherapy in people with Lentigo Maligna, run by Melanoma and Skin Cancer Trials Limited at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lentigo Maligna
- What is being tested?
- Imiquimod and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 31 Aug 2015to 30 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Princess Alexandra Hospital
Brisbane, Queensland, 4102
The Alfred Hospital
Melbourne, Victoria, 3004
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Melanoma Institute Australia
North Sydney, New South Wales, 2060
Skin and Cancer Foundation
Sydney, New South Wales, 2010
Westmead Hospital
Sydney, New South Wales, 2145
St Vincent's Hospital, Sydney
Sydney, New South Wales
About this study
Official 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
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.
Read the detailed description
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. It is approved and widely used in Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts, and perianal warts. 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.
This trial will scientifically evaluate and compare these two treatments in a controlled clinical setting.
The primary objective of this trial is to compare the rate of LM treatment failure and recurrence rate measured at 24 months (primary endpoint), and measured at 6, 12 months (secondary endpoints) following treatment with ImiQ or RT. For this study, treatment failure includes both the recurrence and persistence of LM, and is defined as the presence of LM cells within the original field of treatment confirmed by histopathology.
- Conditions
- Lentigo Maligna
- Being tested
- Imiquimod, Radiotherapy
- Keywords
- Lentigo maligna, Imiquimod, Radiotherapy
- Medical subject headings
- Hutchinson's Melanotic Freckle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Aldara
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing LM treatment failure
Determined by systematic biopsy, 6 months following completion of treatment.
Measured: 6 months
Secondary outcomes (5)
LM treatment failure at 12 months and 24 months after the completion of treatment.
Determined by dermoscopy and/or Reflectance Confocal Microscopy and confirmed by biopsy
Measured: 12 and 24 months
Quality of life using Skindex-16 questionnaire
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.
Measured: 0-24 months
Quality of life using Skindex-29 questionnaire
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.
Measured: 0-24 months
Cosmetic outcome 24 months after treatment or at treatment failure
Evaluated using photographs taken of LM lesion(s) during the study
Measured: 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
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.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start31 Aug 2015
- Primary completion24 Dec 2021
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lentigo MalignaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Melanoma Institute Australia
- Responsible party
- Sponsor
- Investigators
- Pascale Guitera, Principal investigator, Melanoma Institute Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394132
- Sponsor's protocol ID
- 02.12
- Acronym
- RADICAL
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2015
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02394132
- Acronym / sponsor ID
- RADICAL / 02.12
- Conditions
- Lentigo Maligna
- Keywords
- Lentigo maligna, Imiquimod, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Melanoma and Skin Cancer Trials LimitedUniversity, hospital or other
- Collaborators
- Melanoma Institute Australia
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. It is approved and widely used in Australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts, and perianal warts. 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.
This trial will scientifically evaluate and compare these two treatments in a controlled clinical setting.
The primary objective of this trial is to compare the rate of LM treatment failure and recurrence rate measured at 24 months (primary endpoint), and measured at 6, 12 months (secondary endpoints) following treatment with ImiQ or RT. For this study, treatment failure includes both the recurrence and persistence of LM, and is defined as the presence of LM cells within the original field of treatment confirmed by histopathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imiquimod | Experimental | Drug: ImiquimodTopical 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 |
| Radiotherapy | Experimental | Radiation: RadiotherapyRadiotherapy * treatment regimen determined by treating radiation oncologist and as per standard practice at local institution * treatment to commence within 8 weeks of randomisation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodAlso: Aldara | Drug | Imiquimod |
| Radiotherapy | Radiation | Radiotherapy |
Primary outcome
Proportion of patients experiencing LM treatment failure
Time frame: 6 months
Determined by systematic biopsy, 6 months following completion of treatment.
5 secondary outcomes
LM treatment failure at 12 months and 24 months after the completion of treatment.
Time frame: 12 and 24 months
Quality of life using Skindex-16 questionnaire
Time frame: 0-24 months
Quality of life using Skindex-29 questionnaire
Time frame: 0-24 months
Cosmetic outcome 24 months after treatment or at treatment failure
Time frame: 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
Time frame: 0-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Related trials for Lentigo Maligna
Active, not recruitingPhase 2
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Recruiting
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Skin Cancer, Cutaneous Tumor
RecruitingObservational study
Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale Guitera principal investigator
Melanoma Institute Australia
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imiquimod and Radiotherapy in people with Lentigo Maligna, run by Melanoma and Skin Cancer Trials Limited at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Brazil, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients experiencing LM treatment failure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.