Topical Imiquimod in Treating Patients with Persistent HPV-Infection after Surgical or Radiation Treatment of Cervical Cancer - TACTIQ (Treatment after Cervical Cancer with topical Imiquimod)-trial

Phase 1

Conditions: Patients with positive high risk HPV-test 6 months after surgical or radiation treatment for cervical cancer are eligible for this trial. After signing informed consent patients are randomized to HPV-testing after 20 weeks or topical treatment with imiquimod for 16 weeks. The study's primary endpoint is HPV-clearance 20 weeks after randomization.
MedDRA version: 12.1Level: LLTClassification code 10008229Term: Cervical cancer
MedDRA version: 12.1Level: LLTClassification code 10064328Term: Human papilloma virus test positive

Registration Number: EUCTR2010-019657-18-AT

Lead Sponsor: Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Gynäkologie und Gyn.Onkologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Patient aged 18 years or older after surgical or radiation treatment for cervical cancer
positive high risk HPV-test 6 months after treatment
signed informed consent
negative urine pregnancy test (only applicable for patients after radiation treatment)
safe contraception (only applicable for patients after radiation treatment)
Able to communicate well with the investigator, to understand and comply with the requirements of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
Participance in another clinical trial within 30 days
Immunosuppression (medication, illness)
HIV- or Hepatitis infection
histologically proven cervical cancer recurrence