Chemotherapy with or without surgery in treating patients with stage II or III ovarian cancer

ISRCTN ISRCTN84121653
DOI https://doi.org/10.1186/ISRCTN84121653
ClinicalTrials.gov number NCT00003695
Secondary identifying numbers OV06
Submission date
06/04/2000
Registration date
06/04/2000
Last edited
25/01/2019
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

Ms Sarah Wheeler
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 to request a patient information sheet
Scientific titleA randomised trial of interval debulking surgery in epithelial ovarian cancer suboptimally debulked at primary surgery
Study objectivesTo determine the impact of interval debulking surgery in newly diagnosed ovarian cancer in patients with residual macroscopic disease after surgery.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOvarian cancer
InterventionOne group interval debulking surgery/control
Intervention typeProcedure/Surgery
Primary outcome measureSurvival, progression-free survival and quality of life
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1998
Completion date26/07/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants1000
Key inclusion criteria1. Newly diagnosed, histologically confirmed epithelial ovarian cancer
2. International Federation of Gynecology and Obstetrics (FIGO) stage II, III or IV
3. Residual macroscopic disease more than 1 cm in diameter documented at primary surgery or post-operatively by imaging
4. Patient planned to receive platinum-based chemotherapy
5. Patient fit for interval debulking surgery
6. No concomitant or previous malignancy likely to interfere with protocol treatments or comparisons
7. Written informed consent
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/1998
Date of final enrolment26/07/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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

25/01/2019: No publications found, verifying study status with prinicipal investigator
19/02/2018: No publications found, verifying study status with principal investigator.