RADICAL: Radiotherapy or Imiquimod in Complex Lentigo Maligna

Sponsor

Melanoma and Skin Cancer Trials Limited (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02394132

Collaborator

Melanoma Institute Australia (Other)

216

Enrollment

Locations

Arms

Anticipated Duration (Months)

21.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lentigo Maligna	Drug: Imiquimod Radiation: Radiotherapy	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 31, 2015

Actual Primary Completion Date :

Dec 24, 2021

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Imiquimod Other Names: Aldara
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	Radiation: Radiotherapy

Arm

Intervention/Treatment

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

Drug: Imiquimod

Other Names:

Aldara

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

Radiation: Radiotherapy

Outcome Measures

Primary Outcome Measures

Proportion of patients experiencing LM treatment failure (as determined by systematic biopsy) 6 months following completion of treatment. [6 months]

Secondary Outcome Measures

LM treatment failure at 12 months and 24 months after the completion of treatment. [12 and 24 months]
Quality of life using Skindex questionnaire [0-24 months]
Cosmetic outcome 24 months after treatment or at treatment failure [24 months]
Evaluated using photographs taken of LM lesion(s) during the study
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 [0-24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Calvary Mater Newcastle	Newcastle	New South Wales	Australia	2298
2	Melanoma Institute Australia	North Sydney	New South Wales	Australia	2060
3	Skin and Cancer Foundation	Sydney	New South Wales	Australia	2010
4	Westmead Hospital	Sydney	New South Wales	Australia	2145
5	St Vincent's Hospital, Sydney	Sydney	New South Wales	Australia
6	Princess Alexandra Hospital	Brisbane	Queensland	Australia	4102
7	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
8	The Alfred Hospital	Melbourne	Victoria	Australia	3004
9	Hospital das Clinicas, University of Sao Paulo	São Paulo		Brazil
10	North Shore Hospital	Takapuna	Auckland	New Zealand	0740