Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer
| ISRCTN | ISRCTN78953383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78953383 |
| Protocol serial number | G31 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 02/02/2012
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian Cancer |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/1991 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/1991 |
| Date of final enrolment | 01/03/1991 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/08/1992 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
