A placebo-controlled trial of nimodipine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer
| ISRCTN | ISRCTN66284161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66284161 |
| Protocol serial number | G37 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 15/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 | Placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A placebo-controlled trial of nimodipine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer |
| 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. Arm A: Placebo tablet 2. Arm B: Nimopidine tablet |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nimopidine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Key inclusion criteria | 1. Confirmed diagnosis of invasive epithelial ovarian cancer 2. International Federation of Gynaecology and Obstetrics (FIGO) stages Tc - Tv 3. 18-70 years old 4. Performance Status less than or equal to 2 5. White Blood Cells at least 4 x 10^9/l 6. Platelets at least 120 x 10^9/l 7. Creatinine or Ethylene Diamine Tetraacetic Acid (EDTA) clearance greater than or equal to 60 ml/min 8. Normal Bilirubin 9. Serum glutamic-oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) less than or equal to twice normal limit 10. No previous chemotherapy or radiotherapy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1989 |
| Date of final enrolment | 01/01/1993 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/01/2019: The public and scientific titles have been changed from "A placebo-controlled trial of nimopidine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer" to "A placebo-controlled trial of nimodipine with cyclophosphamide/cisplatin for the treatment of advanced ovarian cancer". No publications definitively identified. All search options exhausted.
