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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ioannis Bassukas, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01212549
First received: September 29, 2010
Last updated: August 31, 2011
Last verified: August 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014