Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
18 Years
N/A
Both
Lentigo Maligna Melanoma (Head or Neck)
Trial Information
Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
The primary endpoint of the study is to demonstrate that neoadjuvant treatment of LM by
imiquimod prior to surgery can reduce the frequency of intralesional excisions as from the
first surgical procedure, with a healthy tissue margin of 5mm. Furthermore, the improvement
in patient quality of life could also be significant.
The number of patients to be included in the study is 268.
For each patient, the study will involve several stages (S), as follows:
S0 (Selection): information and obtaining of the patient's informed consent. Performance of
biopsy for histological confirmation of LM
S1 (S0 + ~ 2 weeks): patient inclusion following anatomopathological confirmation of LM.
Patient randomisation in one or other study arm: imiquimod versus placebo and initiation of
topical treatment.
S2 (S1 + 4 weeks): Discontinuation of imiquimod/placebo application. Scheduling of the
surgical procedure 4 weeks later.
S3 (S2 + 4 weeks): Surgery.
S4: After the last surgical procedure, simple clinical follow up will be ensured every 6
months for a period of 3 years, in order to study the recurrence rate.
Inclusion Criteria:
- Patients from both sexes aged over 18 years and operable
- Presenting with LM of the face or the neck, histologically confirmed by biopsy
- Patients presenting with a primitive lesion, of a surface ≥ to 1.5cm² and ≤ to 20cm²,
with the possibility of graft or flap reconstruction
- LM previously untreated by surgery
- LM without prior treatment with liquid nitrogen or any other local treatment within 3
months
- ECOG ≤ 2
- leucocytes ≥ 3,000/mm³
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Haemoglobin ≥ 9.0g/dL
- Absence of severe evolutive infection
- Absence of known HIV infection
- Absence of corticotherapy and treatment by immunosuppressive agents
- Membership to a social security insurance scheme.
- Negative pregnancy test conducted during the inclusion consultation for
non-menopausal women.
- Signed informed consent
Exclusion Criteria:
- LM located on the eyelids are excluded, together with LM in anatomic sites other than
the face or the neck
- Melanomas other than LM
- LM with a surface area < to 1,5cm² or > to 20cm²
- LM of which the macroscopic contours cannot be defined
- Patients treated by immunosuppressive agents, immunomodulators, cytotoxic agents or
corticosteroids (local and systemic) during the 4-week period prior to the selection
visit
- Cutaneous reconstruction not possible
- Presence of associated evolutive neoplasia since less than 5 years (with the
exception of basal cell carcinoma, Bowen's carcinoma and carcinoma in situ of the
cervix)
- Patient refusing surgery under local or general anaesthesia
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm.
Outcome Time Frame:
10 weeks
Safety Issue:
No
Principal Investigator
Brigitte Dréno, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Nantes University Hospital
Authority:
France: ANSM - Agence nationale de sécurité du médicament et des produits de santé
Study ID:
BRD11/06-S
NCT ID:
NCT01720407
Start Date:
October 2012
Completion Date:
June 2017
Related Keywords:
- Lentigo Maligna Melanoma (Head or Neck)
- Dermatology/ Skin cancers/Lentigo maligna melanoma
- Lentigo
- Melanoma
- Hutchinson's Melanotic Freckle
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