North Thames CA125 study in advanced ovarian cancer
| ISRCTN | ISRCTN75843298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75843298 |
| Secondary identifying numbers | NTOG4 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | North Thames CA125 study in advanced ovarian cancer: a randomised controlled trial |
| Study objectives | Five versus eight courses of carboplatin or cisplatin in ovarian cancer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Carboplatin, cisplatin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 05/12/1989 |
| Completion date | 13/04/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 237 |
| Key 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 |
| Key exclusion criteria | Does not comply with above inclusion criteria. |
| Date of first enrolment | 05/12/1989 |
| Date of final enrolment | 13/04/1994 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Follow-up results | 01/04/1996 | Yes | No |
Editorial Notes
27/09/2017: internal review.
