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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Medical University of Vienna
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
ClinicalTrials.gov Identifier:
NCT01283763
First received: January 21, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Cervical Intraepithelial Neoplasia
Drug: Topical Imiquimod
Procedure: Conization
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: ITIC2 Trial - Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia: Randomised Controlled, Non-inferiority Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • HPV clearance [ Time Frame: 6 months after treatment completion ] [ Designated as safety issue: No ]
    non-inferiority of experimental treatment (Imiquimod) to active control (conization)


Secondary Outcome Measures:
  • Rates of CIN remission/regression and/or CIN persistence/regression after treatment [ Time Frame: 6, 12, and 24 months after treatment completion ] [ Designated as safety issue: No ]
    Histologic outcome

  • HPV clearance [ Time Frame: 12 and 24 months after treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT01283763

Contacts
Contact: Stephan Polterauer, M.D. +43140400 ext 2962 stephan.polterauer@meduniwien.ac.at
Contact: Stephan Polterauer +43140400 ext 2962 stephan.polterauer@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Stephan Polterauer, M.D.    +43140400 ext 2962    stephan.polterauer@meduniwien.ac.at   
Contact: Christoph Grimm, M.D.    +43140400 ext 2962    christoph.grimm@meduniwien.ac.at   
Sub-Investigator: Christoph Grimm, M.D.         
Principal Investigator: Stephan Polterauer, M.D.         
Sub-Investigator: Camilla Natter, M.D.         
Sub-Investigator: Alexander Reinthaller, Prof         
Sub-Investigator: Paul Speiser, Prof.         
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:
No publications provided

Responsible Party: Stephan Polterauer, Ass.Prof. MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01283763     History of Changes
Other Study ID Numbers: ITIC2
Study First Received: January 21, 2011
Last Updated: July 15, 2013
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms by Histologic Type
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 25, 2014