Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
4 other identifiers
interventional
150
1 country
70
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before and after surgery works and compares it to giving chemotherapy after surgery alone in treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 13, 2004
CompletedAugust 12, 2013
May 1, 2007
January 9, 2004
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall survival at 3 years
Progression-free survival
Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28)
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (70)
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom
North Devon District Hospital
Barnstaple, England, EX31 4JB, United Kingdom
Royal United Hospital
Bath, England, BA1 3NG, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR, United Kingdom
Bradford Royal Infirmary
Bradford, England, BD9 6RJ, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE, United Kingdom
Broomfield Hospital
Broomfield, England, CM1 7ET, United Kingdom
Cumberland Infirmary
Carlisle, England, CA2 7HY, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN, United Kingdom
Essex County Hospital
Colchester, England, C03 3NB, United Kingdom
Walsgrave Hospital
Coventry, England, CV2 2DX, United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE1 2QY, United Kingdom
Royal Derby Hospital
Derby, England, DE22 3NE, United Kingdom
Birmingham Women's Hospital
Edgbaston, England, B15 2TG, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW, United Kingdom
Frimley Park Hospital
Frimley, England, GU16 5UJ, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX, United Kingdom
Hereford Hospitals
Hereford, England, HR1 2ER, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE, United Kingdom
Ipswich Hospital
Ipswich, England, IP4 5PD, United Kingdom
Royal Lancaster Infirmary
Lancaster, England, LA1 4RP, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Leicester General Hospital
Leicester, England, LE5 4PW, United Kingdom
Lincoln County Hospital
Lincoln, England, LN2 5QY, United Kingdom
Liverpool Women's Hospital
Liverpool, England, L8 7SS, United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
Barts and the London School of Medicine
London, England, EC1M 6GR, United Kingdom
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA, United Kingdom
St. George's Hospital
London, England, SW17 0QT, United Kingdom
Royal Marsden - London
London, England, SW3 6JJ, United Kingdom
Hammersmith Hospital
London, England, W12 OHS, United Kingdom
St. Mary's Hospital
Manchester, England, M13 0JH, United Kingdom
Christie Hospital
Manchester, England, M20 4BX, United Kingdom
Wythenshawe Hospital
Manchester, England, M23 9LJ, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY, United Kingdom
James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD, United Kingdom
Northampton General Hospital
Northampton, England, NN1 5BD, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, 0X3 7LJ, United Kingdom
Derriford Hospital
Plymouth, England, PL6 8DH, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD, United Kingdom
Whiston Hospital
Prescot Merseyside, England, L35 5DR, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, PR2 9HT, United Kingdom
Oldchurch Hospital
Romford, England, RM7 OBE, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S10 2SJ, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, S1O 2JF, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL, United Kingdom
Staffordshire General Hospital
Stafford, England, ST16 3SA, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, England, ST4 7LN, United Kingdom
St. Peter's Hospital
Surrey, England, KT 16 OPZ, United Kingdom
Great Western Hospital
Swindon, England, SN3 6BB, United Kingdom
Taunton and Somerset Hospital
Taunton Somerset, England, TA1 5DA, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
Walsall Manor Hospital
Walsall, England, WS2 9PS, United Kingdom
Good Hope Hospital
West Midlands, England, B75 7RR, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY, United Kingdom
Yeovil District Hospital
Yeovil, England, BA21 4AT, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7BL, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF4 7XL, United Kingdom
South West Wales Cancer Institute
Swansea, Wales, SA2 8QA, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Kehoe
Oxford University Hospitals NHS Trust
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 13, 2004
Study Start
September 1, 2003
Last Updated
August 12, 2013
Record last verified: 2007-05