Spots Global Cancer Trial Database for Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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Trial Identification
Brief Title: Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title: SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers
Study ID: NCT00098878
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sydney Heamatology and Oncology Clinics, Hornsby, New South Wales, Australia
Lismore Base Hospital, Lismore, New South Wales, Australia
Institute of Oncology at Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Tamworth Base Hospital, Tamworth, New South Wales, Australia
Manning Base Hospital, Taree, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital, Wentworthville, New South Wales, Australia
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
Townsville Hospital, Douglas, Queensland, Australia
Mater Adult Hospital, South Brisbane, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Ballarat Oncology and Haematology Services, Ballarat, Victoria, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Royal Women's Hospital, Carlton, Victoria, Australia
Monash Medical Center - Clayton Campus, Clayton, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Mercy Hospital for Women, Heidelberg, Victoria, Australia
Murray Valley Private Hospital and Cancer Treatment Centre, Wodonga, Victoria, Australia
Auckland City Hospital, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Wellington Cancer Centre, Wellington, , New Zealand
Furness General Hospital, Barrow in Furness, England, United Kingdom
Royal United Hospital, Bath, England, United Kingdom
Birmingham Heartlands Hospital, Birmingham, England, United Kingdom
Royal Blackburn Hospital, Blackburn, England, United Kingdom
Blackpool Victoria Hospital, Blackpool, England, United Kingdom
Bradford Royal Infirmary, Bradford, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Broomfield Hospital, Broomfield, England, United Kingdom
Queen's Hospital, Burton-upon-Trent, England, United Kingdom
Cheltenham General Hospital, Cheltenham, England, United Kingdom
Essex County Hospital, Colchester, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
Derbyshire Royal Infirmary, Derby, England, United Kingdom
Dorset County Hospital, Dorchester, England, United Kingdom
Russells Hall Hospital, Dudley, England, United Kingdom
Gloucestershire Royal Hospital, Gloucester, England, United Kingdom
Hereford Hospitals NHS Trust, Hereford, England, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
Ipswich Hospital, Ipswich, England, United Kingdom
Airedale General Hospital, Keighley, England, United Kingdom
Royal Lancaster Infirmary, Lancaster, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Liverpool Women's Hospital, Liverpool, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
University College of London Hospitals, London, England, United Kingdom
Guy's Hospital, London, England, United Kingdom
St. Georges, University of London, London, England, United Kingdom
Hammersmith Hospital, London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital, Maidstone, England, United Kingdom
Christie Hospital, Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital, Margate, England, United Kingdom
Clatterbridge Centre for Oncology, Merseyside, England, United Kingdom
Northampton General Hospital NHS Trust, Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England, United Kingdom
Kings Mill Hospital, Nottinghamshire, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
George Eliot Hospital, Nuneaton, England, United Kingdom
Whiston Hospital, Prescot Merseyside, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital, Preston, England, United Kingdom
Alexandra Healthcare NHS, Redditch, Worcestershire, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Wexham Park Hospital, Slough, Berkshire, 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
Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England, United Kingdom
Weston General Hospital, Weston-super-Mare, England, United Kingdom
Worcester Royal Hospital, Worcester, England, United Kingdom
Worthing Hospital, Worthing, England, United Kingdom
Yeovil District Hospital, Yeovil - Somerset, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast, Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Dumfries & Galloway Royal Infirmary, Dumfries, 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
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom
West Wales General Hospital, Carmarthen, Wales, United Kingdom
South West Wales Cancer Institute, Swansea, Wales, United Kingdom
Contact Details
Name: Stanley B. Kaye, MD, FRCP
Affiliation: Royal Marsden NHS Foundation Trust
Role: STUDY_CHAIR
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