| Trial name or title | RT3VIN EudraCT no: 2006-004327-11 |
|---|---|
| Methods | This is a multi centre trial based in Cardiff UK. This is a randomised phase II trial of two research arms comparing imiquimod and cidofovir |
| Participants | ≥16 years old (102 in each arm) Biopsy proven VIN 3 (including visible perianal disease not extending into the anal canal) , within three months At least one lesion measured using RECIST criteria) with longest diameter ≥ 20mm |
| Interventions | Application three times a week for a maximum of 24 weeks. Should a complete response be observed before 24 weeks, treatment will be stopped and repeat biopsies carried out six weeks later |
| Outcomes | Histologically confirmed complete response by 30 weeks. Symptomatic improvement, concordance and toxicities, viral clearance, HPV integration status and response to treatment and recurrence rate at two years (in complete responders) |
| Starting date | 2008 |
| Contact information | helen.phillips@wctu.wales.nhs.uk, tel: 029 2068 7461 |
| Notes | Completion September 2011 |
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