Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face (ImiReduc)
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Purpose
Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.
Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.
The principal aim of our project is to study the effect of imiquimod versus vehicle in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.
| Condition | Intervention | Phase |
|---|---|---|
|
Lentigo Maligna Melanoma (Head or Neck) |
Drug: Imiquimod cream + surgery Drug: vehicle + surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 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. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- The number of surgical re-excisions required to obtain complete remission. [ Time Frame: Baseline, 2 months till 3 years ] [ Designated as safety issue: No ]
- The number of recurrences, defined as the reappearance of pigmentation within 3 years of surgical excision. [ Time Frame: Baseline, 2 months till 3 years ] [ Designated as safety issue: No ]
- The number of histologically confirmed complete remissions under imiquimod. [ Time Frame: Baseline, 2 months till 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 268 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Imiquimod |
Drug: Imiquimod cream + surgery
Imiquimod (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks (i.e. a total of 20 applications), followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision at 5mm will be performed within a few days (equivalent to 2-stage surgery).
|
| Placebo Comparator: Placebo |
Drug: vehicle + surgery
vehicle (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks, followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision of 5mm of clinically healthy tissue will be performed within a few days (equivalent to 2-stage surgery).
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Amir Khammari | 02 53 48 32 80 | amir.khammari@chu-nantes.fr |
| France | |
| Centre Hospitalier Universitaire de Nantes | Recruiting |
| Nantes, France, 44000 | |
| Principal Investigator: Brigitte Dréno, MD, PhD | |
| Principal Investigator: | Brigitte Dréno, MD, PhD | Nantes University Hospital |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01720407 History of Changes |
| Other Study ID Numbers: | BRD11/06-S |
| Study First Received: | October 23, 2012 |
| Last Updated: | March 14, 2013 |
| Health Authority: | France: ANSM - Agence nationale de sécurité du médicament et des produits de santé |
Keywords provided by Nantes University Hospital:
|
Dermatology/ Skin cancers/Lentigo maligna melanoma |
Additional relevant MeSH terms:
|
Lentigo Melanoma Hutchinson's Melanotic Freckle Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |
ClinicalTrials.gov processed this record on May 22, 2013