A randomised study comparing carboplatin and carboplatin with thalidomide in patients with Stage Ic-IV Ovarian Cancer
| ISRCTN | ISRCTN12694440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12694440 |
| ClinicalTrials.gov (NCT) | NCT00004876 |
| Protocol serial number | 96.084 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 07/12/2012
- 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
Contact information
Dr TS Ganesan
Scientific
Scientific
Oxford Radcliffe Hospital
Oxford
0X3 9DU
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Drugs used in chemotherapy use different ways to stop tumour cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumour. This randomised phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | Patients entering the trial will be randomised to receive carboplatin (every 4 weeks for a maximum of six cycles) only or carboplatin with thalidomide (for 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last cycle of chemotherapy). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Carboplatin, thalidomide |
| Primary outcome measure(s) |
1. Safety |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Histologically confirmed epithelial ovarian cancer 2. Post-menopausal or if pre-menopausal, patients must have had a bilateral salpingo-oophorectomy and/or a total abdominal hysterectomy 3. Stage Ic-IV ovarian cancer 4. Aged over 18 years 5. World Health Organisation (WHO) performance status 0, 1 or 2 6. Written informed consent 7. No previous carboplatin/cisplatin treatment for ovarian cancer 8. No other current invasive malignancy 9. Neither pregnant or with the ability to become pregnant 10. No chronic neurological disease causing peripheral neuropathy 11. No diabetes mellitus |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/1999 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Oxford Radcliffe Hospital
Oxford
0X3 9DU
United Kingdom
0X3 9DU
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 | 01/08/2011 | Yes | No |
