| Source of record | UK Trials |
| ISRCTN | ISRCTN75843298 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | NTOG4 |
| Public title | North Thames CA125 study in advanced ovarian cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Ovarian cancer |
| Study hypothesis | Five versus eight courses of carboplatin or cisplatin in ovarian cancer. |
| 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 diagnosis of invasive epithelial ovarian carcinoma
2. International Federation of Gynaecology and Obstetrics (FIGO) stage Ic, II, III or IV
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. Aged 18 - 75 years
5. Adequate renal, hepatic and bone marrow function
6. Life expectancy of at least 3 months
7. No history of previous malignancy, except basal cell carcinoma of the skin or in situ carcinoma of the cervix
8. No medical contra-indications to protocol treatments |
| Participants - exclusion criteria | Does not comply with above inclusion criteria. |
| Patient information material |
|
| Anticipated start date | 05/12/1989 |
| Anticipated end date | 13/04/1994 |
| Status of trial | Completed |
| Target number of participants | 237 |
| Interventions | Patients are randomised to one of two treatment schedules:
1. Schedule A: Carboplatin or cisplatin repeated every four weeks for a total of five courses. CA125 measurement to be carried out prior to each course.
2. Schedule B: Carboplatin or cisplatin repeated every four weeks for a total of eight courses. CA125 measurement to be carried out prior to each course. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/8805927 |
| Sources of funding | Not provided at time of registration |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| 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 | ISRCTN75843298 |
| Date last extracted from ISRCTN register | 17/04/2008 |
