Chemotherapy with or without surgery in treating patients with stage II or III ovarian cancer
| ISRCTN | ISRCTN84121653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84121653 |
| ClinicalTrials.gov number | NCT00003695 |
| Secondary identifying numbers | OV06 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 25/01/2019
- 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
Ms Sarah Wheeler
Scientific
Scientific
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 to request a patient information sheet |
| Scientific title | A randomised trial of interval debulking surgery in epithelial ovarian cancer suboptimally debulked at primary surgery |
| Study objectives | To determine the impact of interval debulking surgery in newly diagnosed ovarian cancer in patients with residual macroscopic disease after surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | One group interval debulking surgery/control |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Survival, progression-free survival and quality of life |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/1998 |
| Completion date | 26/07/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Newly diagnosed, histologically confirmed epithelial ovarian cancer 2. International Federation of Gynecology and Obstetrics (FIGO) stage II, III or IV 3. Residual macroscopic disease more than 1 cm in diameter documented at primary surgery or post-operatively by imaging 4. Patient planned to receive platinum-based chemotherapy 5. Patient fit for interval debulking surgery 6. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons 7. Written informed consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/1998 |
| Date of final enrolment | 26/07/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Editorial Notes
25/01/2019: No publications found, verifying study status with prinicipal investigator
19/02/2018: No publications found, verifying study status with principal investigator.
