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| [ ...Back to search results ] | [ Print-friendly version ] |
| A Randomised phase II multi-centre Trial of topical treatment in women with Vulval Intraepithelial Neoplasia |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN34420460 |
| Date ISRCTN assigned | 25/09/2007 |
| Local reference number(s) | WCTU004; Sponsor ref: SPON CU 245 |
| Public title | A Randomised phase II multi-centre Trial of topical treatment in women with Vulval Intraepithelial Neoplasia |
| Scientific title | |
| Acronym | RT3 VIN |
| Disease/condition/study domain | Vulval Intraepithelial Neoplasia |
| 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. |
| Design/methodology | A randomised phase II multi-centre trial. |
| Research ethics review | To be submitted as of 03/09/2007. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 01/01/2013 |
| Status of trial | Ongoing |
| Target number of participants | 204 (102 in each arm) |
| Interventions | 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. |
| Primary outcome measure(s) | Histologically confirmed complete response by 30 weeks after start of treatment. |
| Secondary outcome measure(s) | 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 |
| Trial website | http://www.wctu.org.uk |
| Sources of funding | Cancer Research UK (C10087/A7736) |
| Sponsor name | Cardiff University (UK) |
| Sponsor details | Research and Commercial Division 7th Floor 30-36 Newport Road Cardiff United Kingdom CF24 0DE |
| Sponsor telephone | +44 (0)2920 875834 |
| Sponsor fax | +44 (0)2920 874189 |
| Sponsor email | DaviesKP2@cf.ac.uk |
| Contact name | Prof Alison Fiander |
| Contact details | Department of Obstetrics and Gynaecology Cardiff University Heath Park Cardiff United Kingdom CF14 4XW |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34420460 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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