Contact information
Type
Scientific
Primary contact
Mr Nigel Acheson
ORCID ID
Contact details
City Hospital NHS Trust
Dudley Road
Birmingham
B18 7QH
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
845
Study information
Scientific title
Phase I/II randomised study on pre-operative chemotherapy in advanced ovarian cancer
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Carboplatin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1997
Overall trial end date
01/10/1999
Reason abandoned
Eligibility
Participant inclusion criteria
Recruitment target: 60 patients with extra-ovarian spread carcinoma randomised to pre-operative chemotherapy vs standard treatment
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1997
Recruitment end date
01/10/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
City Hospital NHS Trust
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive West Midlands (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary