Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

30/11/2015: no publications found on PubMed.