Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
- Conditions
- Vulvar Intraepithelial Neoplasia
- Interventions
- Procedure: Surgery
- Registration Number
- NCT01861535
- Lead Sponsor
- Medical University of Graz
- Brief Summary
To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- Histologically confirmed VIN (only usual type, formerly VIN 2-3)
- Visible, measurable lesion(s)
- Contraception (for premenopausal women)
- Evidence of invasion
- History of cancer or severe inflammatory dermatosis of the vulva
- Pregnancy, lactation
- Immunodeficiency
- Any treatment for VIN within the previous three months
- Known hypersensitivity to imiquimod
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary surgery Surgery The type of surgery (excision or ablation) will be based on clinical findings and surgeon's judgement. After excision the specimen will be histologically analyzed to assess resection margins and rule out invasion. Primary Imiquimod Imiquimod Treatment with imiquimod will be patient self-administered for a period of 4 months with possible extension to 6 months. A thin layer of imiquimod cream should be applied to the lesion and remain overnight without a cover. Application will be once a week for 2 weeks, then twice a week the following 2 weeks and, if tolerated, 3 times a week for the last weeks. In case of severe side-effects the number of applications can be reduced; a treatment-free period of no more than 1 week is permitted
- Primary Outcome Measures
Name Time Method Complete clinical response 6 months No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size
- Secondary Outcome Measures
Name Time Method HPV status 12 months HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.
Clinical response/ lesion size 6 months Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction).
Histologic response 6 months At baseline punch biopsies will be taken from the affected areas. The site of the initial biopsy will be photodocumented to ensure that the follow-up biopsy at 6 months is taken from the same site. Histologic results will be classified as response (R): complete disappearance of usual type VIN or reduction to VIN1,or no response (NR). All biopsy samples will be analysed independently by two experienced gynecologic pathologists unaware of the treatment allocation
Extent of surgery 12 months The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)
Clinical response/lesion size 12 months Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction).
Trial Locations
- Locations (9)
Department of Gynecology and Obstetrics, Medical University of Innsbruck
🇦🇹Innsbruck, Austria
Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz
🇦🇹Graz, Styria, Austria
Department of Obstetrics and Gynecology/ Medical University of Graz
🇦🇹Graz, Austria
Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt
🇦🇹Klagenfurt, Austria
Dep. of Gynecology and Obstetrics
🇦🇹Leoben, Austria
Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz
🇦🇹Linz, Oberösterreich, Austria
Department of General Gynecology and Gynecology Oncology, Medical University of Vienna
🇦🇹Vienna, Austria
Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz
🇦🇹Linz, Austria
Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria