The role of radical surgery in advanced epithelial ovarian cancer
ISRCTN | ISRCTN62526210 |
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DOI | https://doi.org/10.1186/ISRCTN62526210 |
Secondary identifying numbers | OV3006 |
- 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
Study design | Randomised controlled trial |
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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 below to request a patient 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 | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1990 |
Completion date | 31/12/1995 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Female |
Target number of participants | Not provided at time of registration |
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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
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kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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
30/10/2019: No publications found, all search options exhausted, study status unverified.