Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia (ITIC2)
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| ClinicalTrials.gov Identifier: NCT01283763 |
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Recruitment Status :
Terminated
(poor recruitment)
First Posted : January 26, 2011
Last Update Posted : November 1, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Intraepithelial Neoplasia | Drug: Topical Imiquimod Procedure: Conization | Phase 3 |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Topical Imiquimod
16 weeks topical Imiquimod
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Drug: Topical Imiquimod
16 weeks
Other Name: Aldara® |
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Active Comparator: Conization
Large loop excision of the transformation zone
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Procedure: Conization
Large loop excision of the transformation zone |
- HPV clearance [ Time Frame: 6 months after treatment completion ]non-inferiority of experimental treatment (Imiquimod) to active control (conization)
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Women aged ≥18 years diagnosed with histologically verified CIN 3 and women aged ≥ 30 years diagnosed with CIN 2
- Satisfactory colposcopy
- Signed informed consent
- Negative pregnancy test
- Appropriate contraception method for fertile women during active study period
- Adequate compliance
Exclusion criteria:
- Adenocarcinoma in situ
- History of previous conization
- Malignant disease at the time of inclusion
- Colposcopy suspicious for invasive disease
- Pregnancy and lactation period
- Known allergy or intolerance to IMQ
- Contraindications to conization or IMQ
- Symptoms of a clinically relevant disease
- Known HIV infection
- Evidence of a clinically significant immunodeficiency
- Current, reported participation in another experimental, interventional protocol
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
| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Stephan Polterauer, MD | Medical University of Vienna | |
| Study Director: | Stephan Polterauer, MD | Medical University of Vienna |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stephan Polterauer, Ass.Prof. MD, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01283763 |
| Other Study ID Numbers: |
ITIC2 |
| First Posted: | January 26, 2011 Key Record Dates |
| Last Update Posted: | November 1, 2016 |
| Last Verified: | October 2016 |
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Cervical Intraepithelial Neoplasia, Imiquimod, conization |
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Imiquimod Neoplasms Carcinoma in Situ Uterine Cervical Dysplasia Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Precancerous Conditions Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |