Condition category
Cancer
Date applied
03/09/2007
Date assigned
25/09/2007
Last edited
13/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Alison Fiander

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Cardiff University
Heath Park
Cardiff
CF14 4XW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WCTU004; Sponsor ref: SPON CU 245

Study information

Scientific title

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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

01/01/2013

Reason abandoned

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

Patient

Age group

Adult

Gender

Female

Target number of participants

204 (102 in each arm)

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

Trial 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
United Kingdom
+44 (0)2920 875834
DaviesKP2@cf.ac.uk

Sponsor type

University/education

Website

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

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25304851

Publication citations

  1. Results

    Tristram A, Hurt CN, Madden T, Powell N, Man S, Hibbitts S, Dutton P, Jones S, Nordin AJ, Naik R, Fiander A, Griffiths G, Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT(3)VIN): a multicentre, open-label, randomised, phase 2 trial., Lancet Oncol., 2014, doi: 10.1016/S1470-2045(14)70456-5.

Additional files

Editorial Notes