| Source of record | UK Trials |
| ISRCTN | ISRCTN48397858 |
| Date ISRCTN assigned | 15/10/2002 |
| Local reference number(s) | PACMAIN |
| Public title | A randomised trial of maintenance weekly paclitaxel versus observation following remission with first-line induction carboplatin and paclitaxel for patients with ovarian cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Ovarian Cancer |
| Study hypothesis | It is intended that this study will run in the UK, mainland Europe and Australasia. If the study proves positive, it will require confirmation and will raise the question of whether weekly paclitaxel given for longer periods maybe even more effective. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information required at time of registration. |
| Countries of trial | United Kingdom, Europe, Australasia |
| Participants - inclusion criteria | 1. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer
2. Female, aged 18 years and over
3. International Federation of Gynecology and Obstetrics (FIGO) stage III to IV. Receive six cycles of carboplatin/paclitaxel, three-weekly at registration
4. Able to complete quality of life questionnaires
5. Can comply with follow-up requirements. Written informed consent
6. Response to induction treatment (as demonstrated by a Computed Tomography [CT] scan) |
| Participants - exclusion criteria | 1. Patients with peritoneal carcinomatosis of 'uncertain' origin which is mucin-secreting
2. Histological evidence of an origin in the gastrointestinal tract, bilary system or lung |
| Patient information material |
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| Anticipated start date | 16/12/2002 |
| Anticipated end date | 01/03/2005 |
| Status of trial | Completed |
| Target number of participants | 1200 |
| Interventions | Maintenance chemotherapy: paclitaxel 70 mg/m^2 weekly, beginning three weeks after the last cycle of carboplatin/paclitaxel induction therapy and continuing for 15 weeks. |
| Primary outcome measure(s) | Progression free survival |
| Secondary outcome measure(s) | Not applicable |
| Sources of funding | Institute of Cancer Research (UK) |
| Sponsor name | The Institute of Cancer Research (UK) |
| Sponsor details | 123 Old Brompton Road
London
United Kingdom
SW7 3RP |
| Sponsor telephone | +44(0) 20 7352 8133 |
| Sponsor fax | +44(0) 20 7370 5261 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.icr.ac.uk |
| Contact name | Prof Martin Gore |
| Contact details | Skin & Melanoma Unit
Royal Marsden NHS Foundation Trust
Fulham Road
Chelsea
London
United Kingdom
SW3 6JJ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN48397858 |
| Date last extracted from ISRCTN register | 17/04/2008 |
