Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

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Brief Title

Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

Official Title

Phase 3 Randomized Controlled Trial of Non-inferiority of Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

Brief Summary

      OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to
      3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop
      electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has
      been recognized that these procedures can increase the risks for pre-term labor in women who
      still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a
      topical immune response modulator, has significant effects on histological regression of CIN
      2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may
      be preferable offering similar outcomes on histological regression when compared with
      excision or ablation while potentially avoiding or reducing the number of surgical procedure
      that places them at risk for future pregnancies.
    

Detailed Description

      MATERIALS AND METHODS: A randomized controlled trial of patients with CIN 2-3 to receive
      either surgical excision with LEEP or CKC versus medical therapy with Imiquimod once weekly
      inserted vaginally for 16 weeks. Inclusion criteria are women age 21 years or older with
      confirmed histological diagnosis of CIN 2-3 with a normal endocervical curettage (ECC) if
      obtained and satisfactory colposcopy (the transformation zone of the cervix was completely
      visualized.) Exclusion criteria include positive CIN2-3 on ECC, presence of cancer, pregnancy
      or lactation, immune deficiency, hepatitis, or hypersensitivity to Imiquimod. Patients will
      be randomized to receive excision with LEEP/CKC or Imiquimod 250 mg (5%) cream (12.5 mg of
      active ingredient) inserted vaginally once a week for 16 weeks.

      The primary outcome will be histological regression to CIN 1 or less. Secondary outcomes will
      be complete histological regression, high-risk Human Papilloma Virus (HPV) clearance,
      Clearance of HPV 16, 18/45, and patient tolerance of Imiquimod regimen. Follow up with repeat
      pap, HPV typing to include 16 and 18/45 subtyping, and colposcopy with directed cervical
      biopsy will be performed at 6 months post initiation of treatment. Patients unable to
      complete at least 8 treatments and miss two treatments consecutively will be considered
      failures and offered immediate LEEP. Those patients that complete 8 treatments of Imiquimod
      will be reevaluated 6 months from initiating treatment. Demographic information will be
      obtained to include age, gravidity and parity, smoking history, and contraceptive use.

      Descriptive statistics will include numbers and rates of occurrence with confidence intervals
      of regression, pre, and post-treatment HPV including HPV 16 and 18/45 typing, and adverse
      effects. The assumed regression rate for the LEEP arm varies within studies. We are choosing
      a conservative estimate of 85% regression rate from CIN2+ to CIN1 or less. More recently in a
      2014 publication in the Journal of Virology (Author Antonio Frega, Journal of Clinical
      Virology 60 (2014) 39-43) 13% of the LEEP patients out of 475 had residual disease after
      LEEP. In this study they excluded the 10% of patients that had had positive margins on their
      LEEP specimen. We are not excluding them as this is intent to treat study. For Imiquimod the
      Grimm study found a 73.3% regression rate with those treated with the active ingredient. A
      non-inferiority-type design for two proportions using differences is used in which the
      difference between treatments is defined as medical treatment being preferable if the
      regression rate is not more than 15% below that of the excisional treatment. Comparison of
      the regression rates of the two treatments will be made by a non-inferiority Fisher's exact
      test.

      Required sample size was assessed using the PASS software of the NCSS statistical package.
      Using power = 0.80 and alpha = 0.05, a power analysis predicts the need for 68 patients per
      arm for 136. Post-treatment HPV rates will be compared similarly. We will recruit 75 patients
      to each arm to buffer for a dropout rate.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Human Papillomavirus(HPV) Clearance

Secondary Outcome

 Evidence of local or systemic side effects of Imiquimod cream

Condition

Cervical Intraepithelial Neoplasia

Intervention

Imiquimod

Study Arms / Comparison Groups

 Loop Electrosurgical Excision Procedure
Description:  Excision of the cervical transformation zone by way of the loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

22

Start Date

February 2015

Completion Date

May 9, 2017

Primary Completion Date

December 21, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy women older than age 21, military or civilian

          -  Negative pregnancy test results

          -  Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and
             satisfactory colposcopy visualizing the complete transformation zone of the cervix.

          -  The patient will be available and in the San Diego area for 6 months after enrollment
             to complete the clinic visits and follow up.

        Exclusion Criteria:

          -  Positive CIN 2-3 on ECC

          -  Presence of cancer

          -  Pregnancy or lactation

          -  Immuno-compromised (systemic lupus erythematosus, kidney transplant)

          -  Hepatitis

          -  Hypersensitivity to Imiquimod

          -  Ulcerative colitis

          -  Crohn's disease

          -  Human Immunodeficiency virus
      

Gender

Female

Ages

21 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Addie N Alkhas, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02130323

Organization ID

NMCSD.2014.0040


Responsible Party

Sponsor

Study Sponsor

United States Naval Medical Center, San Diego


Study Sponsor

Addie N Alkhas, MD, Principal Investigator, United States Naval Medical Center, San Diego


Verification Date

June 2017