| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN78953383 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | G31 |
| Public title | Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Ovarian Cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Confirmed diagnosis of invasive epithelial ovarian carcinoma including the following histological subtypes: Serous cystadenocarcinoma; Mucinous cystadenocarcinoma; Endometriod carcinoma; Clear cell (mesonephroid) carcinoma; Undifferentiated carcinoma
2. International Federation of Gynecology and Obstetrics (FIGO) stage Ic, II, III and IV
3. Age 18 -70 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Life expectancy of at least 3 months
6. Adequate bone marrow and renal function
7. No previous chemotherapy or radiotherapy
8. No history of previous malignancy, except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
9. No serious intercurrent disease |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1991 |
| Anticipated end date | 01/03/1991 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Group A: Cisplatin 50 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles
2. Group B: Cisplatin 100 mg/m2 plus 750 mg/m2 cyclophosphamide repeated every 3 weeks for a maximum of six cycles |
| 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 | ISRCTN78953383 |
| Date last extracted from ISRCTN register | 17/04/2008 |
