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Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia (ITIC2)

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ClinicalTrials.gov Identifier: NCT01283763
Recruitment Status : Terminated (poor recruitment)
First Posted : January 26, 2011
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate the non-inferiority of a topical Imiquimod therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e. conization A randomized, controlled, non-inferiority AGO-Austria trial

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Drug: Topical Imiquimod Procedure: Conization Phase 3

Detailed Description:

Background: Alternatives to surgery are needed for the treatment of cervical intraepithelial neoplasia (CIN). CIN is associated with persistent human papillomavirus (HPV) infection and is known to be a potential precursor of cervical cancer. The incidence of CIN has been increasing during the last decades, especially among young women. Patients diagnosed with (persistent) high-grade CIN (CIN2/3) are treated with conization. Conization can be regarded as a safe procedure but peri- and postoperative complications (infections, bleeding, preterm birth) occur. This raises the need for a conservative treatment alternative for patients with high-grade CIN. Preliminary data: Imiquimod (IMQ), a toll-like receptor 7 agonist, is an immune modulating substance approved for the therapy of superficial skin lesions (e.g. basalioma, actinic keratosis) and HPV associated disease (e.g. anogenital condylomata acuminata and vulvar intraepithelial neoplasia). In a randomized, placebo-controlled phase II trial, we previously showed that topical IMQ therapy is an efficacious and feasible treatment for selected patients with CIN 2/3. Methods: In the present open, randomized, non-inferiority trial 500 women with CIN 2/3 will be included. This non-profit, patient-oriented clinical research project will be conducted as an Austrian Gynecologic Oncology Group (AGO-Austria) trial. Participants will be randomized to either 16 weeks treatment with topical IMQ (new treatment) or to standard therapy i.e. conization (active control). This study investigates the non-inferiority of the new treatment, compared to surgical standard treatment. The primary endpoint is the rate of successful treatment, defined as negative HPV test result six months after treatment start. Six months after start of therapy the primary study endpoint is assessed using HPV genotyping. In addition clinical examinations including colposcopy, HPV genotyping, cytology, and if indicated colposcopy-guided biopsies of the uterine cervix will be performed. In addition, rates of CIN persistence/recurrence 6, 12, 18, and 24 months after start of the treatment and rates of negative HPV test results 12 and 24 months after start of the treatment will be evaluated in both treatment groups.

Rationale: The need for a conservative treatment modality for patients diagnosed with CIN is obvious, as many young women need surgical treatment. In this randomized controlled, trial we will investigate the non-inferiority of a topical IMQ treatment compared to surgical standard treatment in selected patients diagnosed with CIN 2/3.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ITIC2 Trial - Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia: Randomised Controlled, Non-inferiority Trial
Study Start Date : May 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Topical Imiquimod
16 weeks topical Imiquimod
Drug: Topical Imiquimod
16 weeks
Other Name: Aldara®
Active Comparator: Conization
Large loop excision of the transformation zone
Procedure: Conization
Large loop excision of the transformation zone


Outcome Measures

Primary Outcome Measures :
  1. HPV clearance [ Time Frame: 6 months after treatment completion ]
    non-inferiority of experimental treatment (Imiquimod) to active control (conization)


Secondary Outcome Measures :
  1. Rates of CIN remission/regression and/or CIN persistence/regression after treatment [ Time Frame: 6, 12, and 24 months after treatment completion ]
    Histologic outcome

  2. HPV clearance [ Time Frame: 12 and 24 months after treatment completion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Women aged ≥18 years diagnosed with histologically verified CIN 3 and women aged ≥ 30 years diagnosed with CIN 2
  2. Satisfactory colposcopy
  3. Signed informed consent
  4. Negative pregnancy test
  5. Appropriate contraception method for fertile women during active study period
  6. Adequate compliance

Exclusion criteria:

  1. Adenocarcinoma in situ
  2. History of previous conization
  3. Malignant disease at the time of inclusion
  4. Colposcopy suspicious for invasive disease
  5. Pregnancy and lactation period
  6. Known allergy or intolerance to IMQ
  7. Contraindications to conization or IMQ
  8. Symptoms of a clinically relevant disease
  9. Known HIV infection
  10. Evidence of a clinically significant immunodeficiency
  11. Current, reported participation in another experimental, interventional protocol
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283763


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Medical University of Graz
Medical University Innsbruck
Krankenhaus Barmherzige Schwestern Linz
Salzburger Landeskliniken
Investigators
Principal Investigator: Stephan Polterauer, MD Medical University of Vienna
Study Director: Stephan Polterauer, MD Medical University of Vienna
More Information

Additional Information:
Responsible Party: Stephan Polterauer, Ass.Prof. MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01283763     History of Changes
Other Study ID Numbers: ITIC2
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Stephan Polterauer, Medical University of Vienna:
Cervical Intraepithelial Neoplasia, Imiquimod, conization

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers