Basal Cell CarcinomaPhase 3IMCXvsCIMTNCT01212549
Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma
A Phase 3 study testing Immunocryosurgery and Cryoimmunotherapy in people with Basal Cell Carcinoma, run by University of Ioannina at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Immunocryosurgery and Cryoimmunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven basal cell carcinoma of the skin
- Size <5cm
- Number of tumors <5 cm
- Distance from eyelids, mouth 0,5cm
Who cannot join
- Size >5cm
- Number of tumors > or =5
- Distance from eyelids or mouth < or =0.5cm
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department for Skin and Venereal Diseases, University Hospital
Ioannina, 45110
About this study
Official title: Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin
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)
Read the 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Immunocryosurgery, Cryoimmunotherapy
- Keywords
- basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunocryosurgeryProcedure or surgery
2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod
CryoimmunotherapyProcedure or surgery
Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod
| Study group | Role | What they receive |
|---|---|---|
| Immunocryosurgery | Active comparator | 2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 weeks imiquimod Receives: Procedure: Immunocryosurgery |
| Cryoimmunotherapy | Active comparator | Cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 5 weeks imiquimod Receives: Procedure: Cryoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Bassukas, University of Ioannina
- Investigators
- Ioannis D Bassukas, Professor, Principal investigator, Medical School, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212549
- Sponsor's protocol ID
- 524270910
- Acronym
- IMCXvsCIMT
- Status last verified
- Aug 2011
- First submitted
- 29 Sep 2010
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1111/j.1468-3083.2009.03224.x. Epub 2009 Jun 25.
PubMed 19555364Bassukas 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.
PubMed 19426725Bassukas 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.
PubMed 18412875Gaitanis 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.
PubMed 20814639
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma of the Skin
- ClinicalTrials.gov ID
- NCT01212549
- Acronym / sponsor ID
- IMCXvsCIMT / 524270910
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunocryosurgery | Active comparator | Procedure: Immunocryosurgery2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 weeks imiquimod |
| Cryoimmunotherapy | Active comparator | Procedure: CryoimmunotherapyCryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 5 weeks imiquimod |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven basal cell carcinoma of the skin
- Size <5cm
- Number of tumors <5 cm
- Distance from eyelids, mouth 0,5cm
Key exclusion criteria (3 listed)
- Size >5cm
- Number of tumors > or =5
- Distance from eyelids or mouth < or =0.5cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunocryosurgery2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod | Procedure or surgery | Immunocryosurgery |
| CryoimmunotherapyCryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod | Procedure or surgery | Cryoimmunotherapy |
Primary outcome
Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Background: PubMed 19555364Gaitanis 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.
- Background: PubMed 19426725Bassukas 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.
- Background: PubMed 18412875Bassukas 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.
- Background: PubMed 20814639Gaitanis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis D Bassukas, Professor principal investigator
Medical School, University of Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunocryosurgery and Cryoimmunotherapy in people with Basal Cell Carcinoma, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212549, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.