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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Ioannis D Bassukas, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical School, University of Ioannina

Authority:

Greece: Ethics Committee

Study ID:

524270910

NCT ID:

NCT01212549

Start Date:

February 2009

Completion Date:

January 2010

Related Keywords:

  • Basal Cell Carcinoma
  • basal cell carcinoma
  • cryosurgery
  • imiquimod
  • immunocryosurgery
  • Carcinoma
  • Carcinoma, Basal Cell

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