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Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia (PITVIN)

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ClinicalTrials.gov Identifier: NCT01861535
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Vulvar Intraepithelial Neoplasia Drug: Imiquimod Procedure: Surgery Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Study Start Date : June 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Primary 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
Drug: Imiquimod
Other Name: Aldara

Active Comparator: Primary 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.
Procedure: Surgery
Other Names:
  • Excision
  • Ablation




Primary Outcome Measures :
  1. Complete clinical response [ Time Frame: 6 months ]
    No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size


Secondary Outcome Measures :
  1. Clinical response/ lesion size [ Time Frame: 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).

  2. Histologic response [ Time Frame: 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

  3. Extent of surgery [ Time Frame: 6 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)

  4. HPV status [ Time Frame: 6 months ]
    HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.

  5. Clinical response/lesion size [ Time Frame: 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).

  6. Extent of surgery [ Time Frame: 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)

  7. HPV status [ Time Frame: 12 months ]
    HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.


Other Outcome Measures:
  1. "Cervical Dysplasia Distress" Questionnaire [ Time Frame: 6 months ]
    Change from baseline in "Cervical Dysplasia Distress" score at 6 months

  2. "Cervical Dysplasia Distress" questionnaire [ Time Frame: 12 months ]
    Change from Baseline in "Cervical Dysplasia Distress" score at 12 months

  3. "Fear of Progression" Questionnaire [ Time Frame: 6 months ]
    Change from Baseline "Fear of Progression" score at 6 months.

  4. "Fear of Progression" questionnaire [ Time Frame: 12 months ]
    Change from Baseline "Fear of Progression" score at 12 months.

  5. "Sexual activity" Questionnaire [ Time Frame: 6 months ]
    Change from baseline "Sexual activity" score at 6 months

  6. "Sexual activity" questionnaire [ Time Frame: 12 months ]
    Change from baseline "Sexual activity" score at 12 months

  7. Immune cells in the epidermis [ Time Frame: 6 months ]
    Histochemical analysis of immune cells from vulvar biopsy samples will be performed at baseline and at 6 months. Frozen sections will be prepared and stained with corresponding cell markers. Immune cell populations will be quantified as number of cells per square millimetre and will be compared between the two treatment groups. The following markers and their primary antibodies will be analysed: CD1a, marker for Langerhans cells, CD94, marker for natural killer cells, CD4, marker for T-helper cells, CD8, marker for cytotoxic T-cells and CD207, marker for immature dendritic cells expressing Langerin.

  8. Aesthetic results [ Time Frame: 6 months ]
    Detailed photos of the overall vulva will be taken. Photos will be compared to photos taken at baseline and judged by 4 independent, blinded observers for aesthetic results.

  9. Aesthetic results [ Time Frame: 12 months ]
    Detailed photos of the overall vulva will be taken. Photos will be compared to photos at baseline and judged by 4 independent, blinded observers for aesthetic results.

  10. Visual analogue scale (VAS) for assessment of pain and pruritus [ Time Frame: 6 months ]
    Change of VAS score for pain and pruritus from baseline to 6 months. VAS will be assessed at baseline, 1,2 ,3,4,5 and 6 months.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed VIN (only usual type, formerly VIN 2-3)
  • Visible, measurable lesion(s)
  • Contraception (for premenopausal women)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT01861535


Contacts
Contact: Gerda Trutnovsky, MD +43 316 385 ext 81081 gerda.trutnovsky@medunigraz.at

Locations
Austria
Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz Recruiting
Linz, Oberösterreich, Austria, 4020
Contact: Peter Oppelt, MD       peter.oppelt@gespag.at   
Sub-Investigator: Angelika Soldan-Salzmann, MD         
Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz Recruiting
Graz, Styria, Austria, 8020
Contact: Christian Schauer, MD       Christian.Schauer@bbgraz.at   
Principal Investigator: Christian Schauer, MD         
Department of Obstetrics and Gynecology/ Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Gerda Trutnovsky, MD    +43 316 385 ext 81081    gerda.trutnovsky@medunigraz.at   
Contact: Olaf Reich, MD    +43 316 385 ext 81616    olaf.reich@medunigraz.at   
Principal Investigator: Gerda Trutnovsky, MD         
Department of Gynecology and Obstetrics, Medical University of Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Andreas Widschendter, MD    +43 50 504 ext 23055    andreas.widschwendter@i-med.ac.at   
Principal Investigator: Andreas Widschwendter, MD         
Sub-Investigator: Alexandra Ciresa-König, MD         
Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt Recruiting
Klagenfurt, Austria
Contact: Manfred Mörtl         
Dep. of Gynecology and Obstetrics Recruiting
Leoben, Austria
Contact: Roland Naglis, MD         
Contact: George Ralph         
Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz Recruiting
Linz, Austria, 4010
Contact: Judith Lafleur, MD       judith.lafleur@bhs.at   
Principal Investigator: Judith Lafleur, MD         
Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Gerhard Bogner, MD       g.bogner@salk.at   
Principal Investigator: Gerhard Bogner, MD         
Department of General Gynecology and Gynecology Oncology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Elmar Joura, MD    +43 1 40400 ext 2915    elmar.joura@meduniwien.ac.at   
Contact: Stephan Polterauer, MD    +43 316 40400    stephan.polterauer@meduniwien.ac.at   
Principal Investigator: Elmar Joura, MD         
Sub-Investigator: Stephan Polterauer, MD         
Sponsors and Collaborators
Medical University of Graz
Austrian Science Fund (FWF)
Investigators
Principal Investigator: Gerda Trutnovsky, MD Medical University of Graz
Study Director: Karl Tamussino, MD Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01861535     History of Changes
Other Study ID Numbers: KLI293
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Medical University of Graz:
VIN
Imiquimod
Surgery
HPV
Patient satisfaction

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers