Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
M M Koeneman, A J Kruse, L F S Kooreman, A Zur Hausen, A H N Hopman, S J S Sep, T Van Gorp, B F M Slangen, H J van Beekhuizen, A J M van de Sande, C G Gerestein, H W Nijman, R F P M Kruitwagen, M M Koeneman, A J Kruse, L F S Kooreman, A Zur Hausen, A H N Hopman, S J S Sep, T Van Gorp, B F M Slangen, H J van Beekhuizen, A J M van de Sande, C G Gerestein, H W Nijman, R F P M Kruitwagen
Abstract
The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (CIN). The lagging inclusions were mainly due to a strong patient preference for either of the two treatment modalities. This prompted us to initiate a new study on the same subject, with a non-randomized, open-label design: the 'TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC)-3' study. Original TOPIC-trial: Medical Ethics Committee approval number METC13231; ClinicalTrials.gov Identifier: NCT02329171, 22 December 2014. TOPIC-3 study: Medical Ethics Committee approval number METC162025; ClinicalTrials.gov Identifier: NCT02917746, 16 September 2016.
Keywords: Biological markers; Cervical intraepithelial neoplasia; Human papillomavirus; Imiquimod; Natural history.
References
- Koeneman MM, Kruse AJ, Kooreman LF, Zur Hausen A, Hopman AH, Sep SJ, Van Gorp T, Slangen BF, van Beekhuizen HJ, van de Sande M, Gerestein CG, Nijman HW, Kruitwagen RF. TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): study protocol for a randomized controlled trial. BMC Cancer. 2016;16:132. doi: 10.1186/s12885-016-2187-3.
Source: PubMed