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Clinical Trials/ACTRN12615000266561
ACTRN12615000266561
Active, not recruiting
Phase 3

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.

Melanoma and Skin Cancer (MASC) Trials0 sites126 target enrollmentMarch 20, 2015

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
entigo maligna (LM)
Sponsor
Melanoma and Skin Cancer (MASC) Trials
Enrollment
126
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 20, 2015
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Melanoma and Skin Cancer (MASC) Trials

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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