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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019657-18-AT

Enrollment

Unknown

Registered

2010-04-28

Start date

2010-06-04

Completion date

Unknown

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 12.1 Level: LLT Classification code 10008229 Term: Cervical cancer MedDRA version: 12.1 Level: LLT Classification code 10064328 Term:

Interventions

Trade Name: Aldara Product Name: Aldara 5% Cream Product Code: EU/1/98/080/001 Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Concentration unit: % percent Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: HPV-clearance 20 weeks after randomization.;Secondary Objective: feasibility; development of cervical dysplasia within 12 months after first line therapy; ;Primary end point(s): high risk HPV-clearance 20 weeks after randomization.	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026