Phase I/II randomised study on pre-operative chemotherapy in advanced ovarian cancer

ISRCTN	ISRCTN19184035
DOI	https://doi.org/10.1186/ISRCTN19184035
Protocol serial number	845
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive West Midlands (UK)

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

City Hospital NHS Trust
Dudley Road
Birmingham
B18 7QH
United Kingdom

Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Carboplatin
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

City Hospital NHS Trust

Birmingham
B18 7QH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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

28/11/2019: No publications found. All search options exhausted.
30/11/2015: no publications found on PubMed.