Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
WCTU004; Sponsor ref: SPON CU 245
Study information
Scientific title
A Randomised phase II multi-centre Trial of topical treatment in women with Vulval Intraepithelial Neoplasia (TR3-VIN)
Acronym
RT3-VIN
Study hypothesis
VIN is a pre-malignant condition that predominantly affects premenopausal women. VIN has a significant invasive potential, is often highly symptomatic and difficult to manage clinically. Severe distressing symptoms of itching and pain are common and management aims to both relieve symptoms and prevent malignant progression. The precise rate of malignant progression is unknown.
Surgery is often chosen as the treatment for this condition but is associated with high rates of recurrence and may be mutilating. By comparison, recent small studies of new topical treatments have shown promising results that warrant further investigation as an alternative to surgery.
The purpose of this research is to determine whether there is evidence that either of the topical treatments is active, safe and feasible to use and would therefore warrant further investigation in a phase III setting.
Ethics approval(s)
To be submitted as of 03/09/2007.
Study design
A randomised phase II multi-centre trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Vulval Intraepithelial Neoplasia
Intervention
Topical treatment with either imiquimod or cidofovir will be applied by the patient for a maximum of 24 weeks. In both treatments the patient should use as much cream as needed to adequately cover the affected area. Patients will be reviewed every 6 weeks. At each visit the lesion will be assessed. In the absence of complete response, treatment will be continued for a maximum of 24 weeks.
Arm A:
Topical imiquimod will be applied three times a week. A thin layer will be spread over the area at night and the area will be washed using aqueous cream and water the following day. Patients will be advised to avoid contact with the treated area, including avoiding sexual intercourse until the area is washed the next day.
Arm B:
Topical cidofovir will be applied three times a week. A thin layer will be spread over the area at night and the area will be washed using aqueous cream and water the following day. Patients will be advised to avoid contact with the treated area, including avoiding sexual intercourse, until the area is washed the next day.
Patients who are judged to have failed on either topical treatment will be given the opportunity to switch to the alternative trial treatment.
Intervention type
Other
Primary outcome measure
Histologically confirmed complete response by 30 weeks after start of treatment.
Secondary outcome measures
1. Symptomatic improvement, assessed at each 6-weekly visit
2. Compliance and side effects, assessed at each 6-weekly visit
3. Viral clearance, assessed 6 weeks after the participants stop treatment
4. Human PapillomaVirus (HPV) type and integration status, assessed 6 weeks after the participants stop treatment
5. Recurrence rate at two years (in 30 week complete responders). This will be assessed 6 monthly for 2 years from the end of treatment visit
Overall study start date
01/01/2008
Overall study end date
01/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women with biopsy proven Vulval Intraepithelial Neoplasia 3 (VIN3) (including visible peri-anal disease not extending into the anal canal)
2. At least one lesion of sufficient size to allow biopsies (greater than or equal to 1 cm2)
3. Informed consent
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
204 (102 in each arm)
Total final enrolment
180
Participant exclusion criteria
1. Any patients with impaired renal function
2. Any patient with current anogenital carcinoma or any patient who, in the investigators opinion, is at a high risk of developing invasive disease (patients in whom invasive or microinvasive disease is suspected should have adequate biopsies to exclude this prior to entry)
3. Pregnancy, breast feeding or trying to conceive
4. Active treatment for VIN within the previous four weeks
5. Patients who are under 18 years old
6. Known allergy to either of the topical treatments
7. Unable to comply with protocol treatment
8. Prior failure of imiquimod or cidofovir following treatment 3 times a week for a minimum of 12 weeks
Recruitment start date
01/01/2008
Recruitment end date
01/01/2013
Locations
Countries of recruitment
United Kingdom, Wales
Study participating centre
Department of Obstetrics and Gynaecology
Cardiff
CF14 4XW
United Kingdom
Sponsor information
Organisation
Cardiff University (UK)
Sponsor details
Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
+44 (0)2920 875834
DaviesKP2@cf.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK (C10087/A7736)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | long-term follow-up results | 01/08/2018 | 05/08/2019 | Yes | No |
| Plain English results | 31/03/2022 | No | Yes |