Clinical trial NCT01212549: Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma
Official title: Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma
cryosurgery
imiquimod
immunocryosurgery
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Department for Skin and Venereal Diseases, University Hospital
Study officials:
affiliation: Medical School, University of Ioannina
name: Ioannis D Bassukas, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaitanis G, Nomikos K, Vava E, Alexopoulos EC, Bassukas ID. Immunocryosurgery for basal cell carcinoma: results of a pilot, prospective, open-label study of cryosurgery during continued imiquimod application. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1427-31. doi: 10.1111/j.1468-3083.2009.03224.x. Epub 2009 Jun 25.
citation: Bassukas ID, Gaitanis G. Combination of cryosurgery and topical imiquimod: does timing matter for successful immunocryosurgery? Cryobiology. 2009 Aug;59(1):116-7. doi: 10.1016/j.cryobiol.2009.04.011. Epub 2009 May 6. No abstract available.
citation: Bassukas ID, Gamvroulia C, Zioga A, Nomikos K, Fotika C. Cryosurgery during topical imiquimod: a successful combination modality for lentigo maligna. Int J Dermatol. 2008 May;47(5):519-21. doi: 10.1111/j.1365-4632.2008.03562.x.
citation: Gaitanis G, Mitsou G, Tsiouri G, Alexis I, Bassukas ID. Cryosurgery during imiquimod cream treatment ("immunocryosurgery") for Bowen's disease of the skin: a case series. Acta Derm Venereol. 2010 Sep;90(5):533-4. doi: 10.2340/00015555-0896. No abstract available.