Phase I/II randomised study on pre-operative chemotherapy in advanced ovarian cancer
ISRCTN | ISRCTN19184035 |
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DOI | https://doi.org/10.1186/ISRCTN19184035 |
Secondary identifying numbers | 845 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 28/11/2019
- 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
Mr Nigel Acheson
Scientific
Scientific
City Hospital NHS Trust
Dudley Road
Birmingham
B18 7QH
United Kingdom
abc@email.com |
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 | Phase I/II randomised study on pre-operative chemotherapy in advanced ovarian cancer |
Study objectives | The proposed study will combine clinical and scientific approaches in trying to improve the treatment of patients with ovarian cancer. The purpose of this programme is to understand the factors promoting rapid tumour regrowth following surgical resection of ovarian cancer and to evaluate the usefulness of chemotherapy given during this period. Aims: To identify the mitogenic agent(s) responsible for post-resection proliferation of tumour cells (the lead compounds are VEGF and LPA) and identify whether production is by tumour cells or during the wound healing response. In this way the researchers hope to identify antagonists for the mitogenic activity that could be developed as a treatment strategy. To assess the safety of pre-operative carboplatin administration in patients with extra ovarian spread of the carcinoma at the time of surgery and the influence of this on survival of patients. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Ovarian cancer |
Intervention | Following randomisation patients will receive intravenous carboplatin either: as per current practice or pre-operatively, at a dose calculated by Calvert's Formula. Patients will be reviewed in the clinic 2 weeks following surgery to discuss the pathological findings and to discuss the future management plan. Follow-up after completion of therapy will be 3 monthly for the first two years and 6 monthly until 5 years. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase I/II |
Drug / device / biological / vaccine name(s) | Carboplatin |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/10/1997 |
Completion date | 01/10/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Female |
Target number of participants | 60 |
Key inclusion criteria | Recruitment target: 60 patients with extra-ovarian spread carcinoma randomised to pre-operative chemotherapy vs standard treatment |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/10/1997 |
Date of final enrolment | 01/10/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
City Hospital NHS Trust
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive West Midlands (UK)
No information available
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
28/11/2019: No publications found. All search options exhausted.
30/11/2015: no publications found on PubMed.