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

ISRCTN ISRCTN19184035
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

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

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePhase I/II randomised study on pre-operative chemotherapy in advanced ovarian cancer
Study objectivesThe 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) studiedOvarian cancer
InterventionFollowing 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
Drug / device / biological / vaccine name(s)Carboplatin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/1997
Completion date01/10/1999

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants60
Key inclusion criteriaRecruitment target: 60 patients with extra-ovarian spread carcinoma randomised to pre-operative chemotherapy vs standard treatment
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/1997
Date of final enrolment01/10/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

City Hospital NHS Trust
Birmingham
B18 7QH
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.