The role of radical surgery in advanced epithelial ovarian cancer
| ISRCTN | ISRCTN62526210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62526210 |
| Protocol serial number | OV3006 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 30/10/2019
- 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 | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The role of radical surgery in advanced epithelial 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 | Patients are randomised to one of two treatment arms: 1. Arm A: High activity platinum based chemotherapy. The recommended chemotherapy regimen is cyclophosphamide and cisplatin given for a maximum of eight cycles. 2. Arm B: Radical debulking surgery followed by chemotherapy as described above. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Key inclusion criteria | 1. Histologically confirmed epithelial ovarian cancer 2. Macroscopic residual disease unlikely in surgeon's opinion to be completely debulked without bowel resection or other procedures 3. No attempt to radically debulk 4. No prior chemotherapy or radiotherapy 5. No previous or concurrent malignancy other than non melanomatous skin cancer 6. No haematological or biochemical contra-indication to platinum chemotherapy 7. No contraindication to second laparotomy 8. Available to commence chemotherapy or undergo further surgery within 6 weeks of diagnostic laparotomy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 31/12/1995 |
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
30/10/2019: No publications found, all search options exhausted, study status unverified.