Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma

Study Overview
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Brief Summary
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To compare the effectiveness of two application schemes of cryosurgery during a 5 week course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks of topical imiquimod (cryoimmunotherapy)

Detailed Description
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Comparison of efficacy Number of patients: N=40 Arms: Two equal arms (20 patients each) Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy Exclusion criteria: (1) Size of the tumors >5cm; (2) Distance from the eyelid <0,5cm; (3)Number of tumors >5 Interim analysis: When at least 10 patients are included in each arm or at the end of the first year of the study The patients will be randomized in 2 groups Group 1 (Immunocryosurgery) and Group 2 (Cryoimmunotherapy) Treatment protocols: Group 1 (Immunocryosurgery): Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. Group 2 (Cryoimmunotherapy): Patients will be submitted into cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) and subsequently will apply imiquimod on the tumor and a rim of 2mm around the tumor for 5 weeks in total. They will be evaluated in week 2 and 5. Patients from both groups will be evaluated at 1, 3, 6, 12 months after termination of imiquimod treatment. In case of clinical relapse, it will be confirmed by biopsy and all the patients will treated with immunocrysurgery.

Official Title
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Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Procedure: Immunocryosurgery
* Procedure: Cryoimmunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven basal cell carcinoma of the skin Size <5cm Number of tumors <5 cm Distance from eyelids, mouth 0,5cm Exclusion Criteria: Size >5cm Number of tumors > or =5 Distance from eyelids or mouth < or =0.5cm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immunocryosurgery<br>2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 weeks imiquimod | Procedure: Immunocryosurgery<br>* 2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod<br>|
| Active Comparator: Cryoimmunotherapy<br>Cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 5 weeks imiquimod | Procedure: Cryoimmunotherapy<br>* Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery