The role of radical surgery in advanced epithelial ovarian cancer

ISRCTN ISRCTN62526210
DOI https://doi.org/10.1186/ISRCTN62526210
Secondary identifying numbers OV3006
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
30/10/2019
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

Dr - -
Scientific

UKCCCR Register Co-ordinator
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 below to request a patient information sheet
Scientific titleThe role of radical surgery in advanced epithelial ovarian cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOvarian cancer
InterventionPatients are randomised to one of two treatment arms:
1. Arm A: High activity platinum based chemotherapy. The recommended chemotherapy regimen is cyclophosphamide and cisplatin given for a maximum of eight cycles.
2. Arm B: Radical debulking surgery followed by chemotherapy as described above.
Intervention typeMixed
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1990
Completion date31/12/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Histologically confirmed epithelial ovarian cancer
2. Macroscopic residual disease unlikely in surgeon's opinion to be completely debulked without bowel resection or other procedures
3. No attempt to radically debulk
4. No prior chemotherapy or radiotherapy
5. No previous or concurrent malignancy other than non melanomatous skin cancer
6. No haematological or biochemical contra-indication to platinum chemotherapy
7. No contraindication to second laparotomy
8. Available to commence chemotherapy or undergo further surgery within 6 weeks of diagnostic laparotomy
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1990
Date of final enrolment31/12/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
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

30/10/2019: No publications found, all search options exhausted, study status unverified.