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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:
Medical University of Graz
Medical University Innsbruck
Krankenhaus Barmherzige Schwestern Linz
Salzburger Landeskliniken
Information provided by (Responsible Party):
Stephan Polterauer, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE January 21, 2011
First Posted Date  ICMJE January 26, 2011
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
HPV clearance [ Time Frame: 6 months after treatment completion ]
non-inferiority of experimental treatment (Imiquimod) to active control (conization)
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
Effectiveness [ Time Frame: 4 weeks after end of treatment of all 220 participants, up to 33 month after study initiation ]
Complete CIN Remission
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
  • Rates of CIN remission/regression and/or CIN persistence/regression after treatment [ Time Frame: 6, 12, and 24 months after treatment completion ]
    Histologic outcome
  • HPV clearance [ Time Frame: 12 and 24 months after treatment completion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
  • HPV clearance [ Time Frame: after 8 weeks of treatment completion ]
    HPV-clearance rate
  • Cellular and molecular mechanisms of HPV immune evasion [ Time Frame: before and after treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia
Official Title  ICMJE ITIC2 Trial - Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia: Randomised Controlled, Non-inferiority Trial
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia
Intervention  ICMJE
  • Drug: Topical Imiquimod
    16 weeks
    Other Name: Aldara®
  • Procedure: Conization
    Large loop excision of the transformation zone
Study Arms  ICMJE
  • Experimental: Topical Imiquimod
    16 weeks topical Imiquimod
    Intervention: Drug: Topical Imiquimod
  • Active Comparator: Conization
    Large loop excision of the transformation zone
    Intervention: Procedure: Conization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 30, 2016)
95
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2011)
220
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01283763
Other Study ID Numbers  ICMJE ITIC2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephan Polterauer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE
  • Medical University of Graz
  • Medical University Innsbruck
  • Krankenhaus Barmherzige Schwestern Linz
  • Salzburger Landeskliniken
Investigators  ICMJE
Principal Investigator: Stephan Polterauer, MD Medical University of Vienna
Study Director: Stephan Polterauer, MD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP