Clinical trial · Interventional
Radiotherapy or Imiquimod in Complex Lentigo Maligna
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
NCT02394132CI-TRIAL-00078071RADICALcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lentigo Maligna | Lentigo Maligna | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imiquimod
- description
- 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
- interventionNames
- Drug: Imiquimod
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Radiotherapy * treatment regimen determined by treating radiation oncologist and as per standard practice at local institution * treatment to commence within 8 weeks of randomisation
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Proportion of patients experiencing LM treatment failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.