| Source of record | UK Trials |
| ISRCTN | ISRCTN12694440 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | 96.084 |
| Public title | A randomised study comparing carboplatin and carboplatin with thalidomide in patients with Stage Ic-IV Ovarian Cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Ovary |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically confirmed epithelial ovarian cancer
2. Post-menopausal or if pre-menopausal, patients must have had a bilateral salpingo-oophorectomy and/or a total abdominal hysterectomy
3. Stage Ic-IV ovarian cancer
4. Aged over 18 years
5. World Health Organisation (WHO) performance status 0, 1 or 2
6. Written informed consent
7. No previous carboplatin/cisplatin treatment for ovarian cancer
8. No other current invasive malignancy
9. Neither pregnant or with the ability to become pregnant
10. No chronic neurological disease causing peripheral neuropathy
11. No diabetes mellitus |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 19/06/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients entering the trial will be randomised to receive carboplatin (every 4 weeks for a maximum of six cycles) only or carboplatin with thalidomide (for 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last cycle of chemotherapy). |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN12694440 |
| Date last extracted from ISRCTN register | 17/04/2008 |
