ISRCTN ISRCTN62526210
DOI https://doi.org/10.1186/ISRCTN62526210
Protocol serial number OV3006
Sponsor Cancer Research UK (CRUK) (UK)
Funder Cancer Research UK
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant 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 measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
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

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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