Spots Global Cancer Trial Database for Radiotherapy or Imiquimod in Complex Lentigo Maligna
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Trial Identification
Brief Title: Radiotherapy or Imiquimod in Complex Lentigo Maligna
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
Study ID: NCT02394132
Conditions
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Skin and Cancer Foundation, Sydney, New South Wales, Australia
Westmead Hospital, Sydney, New South Wales, Australia
St Vincent's Hospital, Sydney, Sydney, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Hospital das Clinicas, University of Sao Paulo, São Paulo, , Brazil
North Shore Hospital, Takapuna, Auckland, New Zealand
Contact Details
Name: Pascale Guitera
Affiliation: Melanoma Institute Australia
Role: PRINCIPAL_INVESTIGATOR
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