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.

• Register: ANZCTR
• Last refreshed on: 24 January 2022
• Main ID: ACTRN12615000266561
• Date of registration: 20/03/2015
• Prospective Registration: Yes
• Primary sponsor: Melanoma and Skin Cancer (MASC) Trials
• 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.
• Date of first enrolment: 31/08/2015
• Target sample size: 266
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12615000266561.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, New Zealand

Contacts

• Name: Mr MASC Coordinator

• Name: Mr MASC Coordinator

Key inclusion & exclusion criteria

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.
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Non melanoma skin cancer

Lentigo maligna (LM);
Lentigo maligna (LM)

Intervention(s)

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

Primary Outcome(s)

Proportion of patients experiencing LM treatment failure (biopsy) 6 months following completion of treatment[6 months after treatment completion]

Secondary Outcome(s)

Dermatology specific patient reported outcomes measured using Skindex questionnaire[Baseline, 4 weeks after starting imiquimod or 4 weeks post radiotherapy, then 3, 6, 12, 18 (optional) and 24 months]

Proportion of patients experiencing LM treatment failure (dermoscopy) 12 and 24 months following treatment[12 and 24 months after treatment completion]

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[0-24 months]

Cosmetic outcome 24 months after treatment or at treatment failure, assessed via photographs taken of the LM lesion(s)[24 months after treatment or at treatment failure]

Secondary ID(s)

MASC 02.12

Source(s) of Monetary Support

Cancer Australia

Secondary Sponsor(s)

Melanoma Institute Australia

Ethics review

Status: Approved
Approval date: 15/06/2015
Contact:

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Results

• Date Posted: 20/01/2022