Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma - Full Text View

Purpose

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)

Condition	Intervention	Phase
Basal Cell Carcinoma	Procedure: Immunocryosurgery Procedure: Cryoimmunotherapy	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:	Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin

Resource links provided by NLM:

Drug Information available for: Imiquimod

U.S. FDA Resources

Further study details as provided by University of Ioannina:

Primary Outcome Measures:

Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	February 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Immunocryosurgery 2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 weeks imiquimod	Procedure: Immunocryosurgery 2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod
Active Comparator: Cryoimmunotherapy Cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 5 weeks imiquimod	Procedure: Cryoimmunotherapy Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212549

Locations

Greece
Department for Skin and Venereal Diseases, University Hospital
Ioannina, Greece, 45110

Sponsors and Collaborators

University of Ioannina

Investigators

Principal Investigator:

Ioannis D Bassukas, Professor

Medical School, University of Ioannina

More Information

Publications:

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. Epub 2009 Jun 25.

Bassukas ID, Gaitanis G. Combination of cryosurgery and topical imiquimod: does timing matter for successful immunocryosurgery? Cryobiology. 2009 Aug;59(1):116-7. Epub 2009 May 6. No abstract available.

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.

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. No abstract available.

Responsible Party:	Ioannis Bassukas, Associate Professor of Dermatology, University of Ioannina
ClinicalTrials.gov Identifier:	NCT01212549 History of Changes
Other Study ID Numbers:	524270910
Study First Received:	September 29, 2010
Last Updated:	August 31, 2011
Health Authority:	Greece: Ethics Committee

Keywords provided by University of Ioannina:

basal cell carcinoma
cryosurgery
imiquimod
immunocryosurgery

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Imiquimod

Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 19, 2013

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