To investigate the effectiveness of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment and to assess long-term disease recurrence, side effects and quality of life associated with different treatment modalities.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions
after imiquimod or conservative management, defined as regression to CIN 1 or
less, at 20 weeks follow-up and adequate treatment of high-grade CIN by LLETZ,
defined as no need for additional treatment within 6 months.
Secondary outcome
1. Side effects of imiquimod therapy and LLETZ therapy as scored by the Common
Terminology Criteria for Adverse Events guidelines.
2. Disease recurrence at 6, 12 and 24 months follow-up, defined as abnormal
cervical cytology for all treatment roups.
3. Quality of life (QoL) before, during and after treatment, assessed by the
following QoL questionnaires at 0 and 20 weeks and after 1 year:
a. Medical Outcomes Study 36-Item Short-Form General Health Survey (RAND 36),
to assess generic health-related quality of life
b. European Organization for Research and Treatment of Cancer (EORTC)
quality-of-life questionnaire: QLQ-C30, to assess cancer-specific
health-related quality of life
c. European Organization for Research and Treatment of Cancer (EORTC)
quality-of-life questionnaire: QLQ-CX24, to assess cervical cancer specific
quality of life, including sexual functioning
Background summary
Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of
cervical cancer. The standard treatment of histologically confirmed CIN2-3
changes is surgical excision, with potential complications, such as hemorrhage,
infection and preterm birth in subsequent pregnancies.
For this reason, adjuvant non-invasive therapies are needed. Imiquimod
(non-invasive immunomodulator) is effective in the treatment of HPV related
vulvar intraepithelial neoplasia (VIN). VIN and CIN have a comparable
pathophysiology, and imiquimod may be effective as well in CIN. However, in
case of CIN, few studies are available and results are not consistent.
Study objective
To investigate the effectiveness of imiquimod 5% cream for the treatment of
CIN2-3 lesions, compared to LLETZ treatment and to assess long-term disease
recurrence, side effects and quality of life associated with different
treatment modalities.
Study design
Single-centre, single blinded randomized controlled intervention trial
Intervention
Patients will be randomized into one of two groups:
1. Imiquimod treatment. Patients in this group are treated by a 16-week regime
of imiquimod 5% cream.
2. Standard treatment. LLETZ will be performed on patients in this group.
A colposcopy will be performed after 10 weeks for the first group. In case of
regression or stable disease, the treatment will be continued for another 10
weeks. In case of progression, LLETZ will be performed. Re-evaluation will be
performed after another 10 weeks, by colposcopy with biopsies. LLETZ wil be
performed in case of persistent or progressive disease.
Study burden and risks
The burden associated with participation includes a questionnaire concerning
demographic and behavioural factors and two control colposcopies for subjects
in the imiquimod group. Subjects allocated to the imiquimod arm will have
cervical application of imiquimod. A LLETZ procedure may not be necessary for
participants of the study when a CIN2/3 lesion regresses spontaneously or
during imiquimod treatment. This may prevent complications, of which we
consider the reduced risk of premature birth as the most important. A small
risk of disease progression during the study cannot be ruled out.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
- age of 18 years or older
Exclusion criteria
- immuno-compromised women,
- pregnant of lactating women,
- legally incapable women
- previous histologically confirmed high grade CIN (CIN 2-3)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-001260-34-NL |
| ClinicalTrials.gov | NCT02329171 |
| CCMO | NL44336.068.13 |