Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00098878
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy.
Secondary
* Compare the toxic effects of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare overall clinical response rate and CA 125 response in patients treated with these regimens.
* Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive a flat dose of carboplatin on day 1.
* Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each treatment course, and then at 2 months post-chemotherapy.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Toxicity Quality of life Clinical overall response rate and CA125 response Overall survival
Trial Locations
- Locations (88)
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Institute of Oncology at Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Tamworth Base Hospital
🇦🇺Tamworth, New South Wales, Australia
Ballarat Oncology and Haematology Services
🇦🇺Ballarat, Victoria, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, England, United Kingdom
Kings Mill Hospital
🇬🇧Nottinghamshire, England, United Kingdom
Dumfries & Galloway Royal Infirmary
🇬🇧Dumfries, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
St. Georges, University of London
🇬🇧London, England, United Kingdom
Hammersmith Hospital
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Royal Women's Hospital
🇦🇺Carlton, Victoria, Australia
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Manning Base Hospital
🇦🇺Taree, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Waratah, New South Wales, Australia
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Lismore Base Hospital
🇦🇺Lismore, New South Wales, Australia
Sydney Heamatology and Oncology Clinics
🇦🇺Hornsby, New South Wales, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
Wellington Cancer Centre
🇳🇿Wellington, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Whiston Hospital
🇬🇧Prescot Merseyside, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Taunton and Somerset Hospital
🇬🇧Taunton Somerset, England, United Kingdom
South Warwickshire Hospital
🇬🇧Warwick, Warwickshire, England, United Kingdom
Weston General Hospital
🇬🇧Weston-super-Mare, England, United Kingdom
Worcester Royal Hospital
🇬🇧Worcester, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Broomfield Hospital
🇬🇧Broomfield, England, United Kingdom
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Mercy Hospital for Women
🇦🇺Heidelberg, Victoria, Australia
Murray Valley Private Hospital and Cancer Treatment Centre
🇦🇺Wodonga, Victoria, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
Monash Medical Center - Clayton Campus
🇦🇺Clayton, Victoria, Australia
Furness General Hospital
🇬🇧Barrow in Furness, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, England, United Kingdom
Alexandra Healthcare NHS
🇬🇧Redditch, Worcestershire, England, United Kingdom
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Hereford Hospitals NHS Trust
🇬🇧Hereford, England, United Kingdom
Airedale General Hospital
🇬🇧Keighley, England, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil - Somerset, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Gartnavel General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
West Wales General Hospital
🇬🇧Carmarthen, Wales, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom