Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-29 @ 10:05 AM
Study NCT ID:
NCT02394132
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy or Imiquimod in Complex Lentigo Maligna
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018327', 'term': "Hutchinson's Melanotic Freckle"}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients experiencing LM treatment failure', 'timeFrame': '6 months', 'description': 'Determined by systematic biopsy, 6 months following completion of treatment.'}], 'secondaryOutcomes': [{'measure': 'LM treatment failure at 12 months and 24 months after the completion of treatment.', 'timeFrame': '12 and 24 months', 'description': 'Determined by dermoscopy and/or Reflectance Confocal Microscopy and confirmed by biopsy'}, {'measure': 'Quality of life using Skindex-16 questionnaire', 'timeFrame': '0-24 months', 'description': 'Patient Reported outcomes were collected using the dermatology specific quality of life instrument Skindex-16 with additional questions specifically selected from the Skindex-29.\n\nThe 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.'}, {'measure': 'Quality of life using Skindex-29 questionnaire', 'timeFrame': '0-24 months', 'description': '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.'}, {'measure': 'Cosmetic outcome 24 months after treatment or at treatment failure', 'timeFrame': '24 months', 'description': 'Evaluated using photographs taken of LM lesion(s) during the study'}, {'measure': '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', 'timeFrame': '0-24 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lentigo maligna', 'Imiquimod', 'Radiotherapy'], 'conditions': ['Lentigo Maligna']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nCurrently, 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.\n\nThis trial will scientifically evaluate and compare these two treatments in a controlled clinical setting.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. A biopsy-proven LM. This includes previous treatment failures (not with imiquimod or RT) of LM that are diagnosed as biopsy-proven LM.\n3. LM that is in a location amenable to treatment with imiquimod and radiotherapy.\n4. Willing and able to comply with study requirements.\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Invasive melanoma.\n2. Medical or psychiatric condition that compromises the ability of the patient to complete protocol treatment or follow-up assessments.\n3. Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry.\n4. Life expectancy of less than 2 years.\n5. Radiotherapy sensitivity syndrome'}, 'identificationModule': {'nctId': 'NCT02394132', 'acronym': 'RADICAL', 'briefTitle': 'Radiotherapy or Imiquimod in Complex Lentigo Maligna', 'organization': {'class': 'OTHER', 'fullName': 'Melanoma and Skin Cancer Trials Limited'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '02.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imiquimod', 'description': 'Topical imiquimod 5% cream\n\n* application to treatment area for 5 days/week for a total of 12 weeks\n* dispensed at baseline visit along with patient diary', 'interventionNames': ['Drug: Imiquimod']}, {'type': 'EXPERIMENTAL', 'label': 'Radiotherapy', 'description': 'Radiotherapy\n\n* treatment regimen determined by treating radiation oncologist and as per standard practice at local institution\n* treatment to commence within 8 weeks of randomisation', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Imiquimod', 'type': 'DRUG', 'otherNames': ['Aldara'], 'armGroupLabels': ['Imiquimod']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2298', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2060', 'city': 'North Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Melanoma Institute Australia', 'geoPoint': {'lat': -33.839, 'lon': 151.2072}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Skin and Cancer Foundation', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital, Sydney", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '0740', 'city': 'Takapuna', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'North Shore Hospital', 'geoPoint': {'lat': -36.79167, 'lon': 174.77583}}], 'overallOfficials': [{'name': 'Pascale Guitera', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melanoma Institute Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melanoma and Skin Cancer Trials Limited', 'class': 'OTHER'}, 'collaborators': [{'name': 'Melanoma Institute Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}