Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OV3006
Study information
Scientific title
The role of radical surgery in advanced epithelial ovarian cancer
Acronym
Study hypothesis
Not provided at time of registration
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
Patients 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 type
Mixed
Phase
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
31/12/1995
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
31/12/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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