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| Sponsor: | NHS Greater Glasgow and Clyde |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098878 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 1300 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer*
If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:
Patient has a pelvis (ovarian) mass AND all of the following:
Initial cytoreductive laparotomy or biopsy required within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine clearance ≥ 30 mL/min
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| Australia, New South Wales | |
| Institute of Oncology at Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Lismore Base Hospital | |
| Lismore, New South Wales, Australia, 2480 | |
| Manning Base Hospital | |
| Taree, New South Wales, Australia, 2430 | |
| Newcastle Mater Misericordiae Hospital | |
| Waratah, New South Wales, Australia, 2298 | |
| Royal North Shore Hospital | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Sydney Cancer Centre at Royal Prince Alfred Hospital | |
| Sydney, New South Wales, Australia, 2050 | |
| Sydney Heamatology and Oncology Clinics | |
| Hornsby, New South Wales, Australia, 2077 | |
| Tamworth Base Hospital | |
| Tamworth, New South Wales, Australia, 2340 | |
| Westmead Institute for Cancer Research at Westmead Hospital | |
| Wentworthville, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Mater Adult Hospital | |
| South Brisbane, Queensland, Australia, 4101 | |
| Royal Brisbane and Women's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Townsville Hospital | |
| Douglas, Queensland, Australia, 4814 | |
| Australia, South Australia | |
| Flinders Medical Centre | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Tasmania | |
| Royal Hobart Hospital | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Ballarat Oncology and Haematology Services | |
| Ballarat, Victoria, Australia, 3350 | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia, 3128 | |
| Frankston Hospital | |
| Frankston, Victoria, Australia, 3199 | |
| Mercy Hospital for Women | |
| Heidelberg, Victoria, Australia, 3084 | |
| Monash Medical Center - Clayton Campus | |
| Clayton, Victoria, Australia, 3168 | |
| Murray Valley Private Hospital and Cancer Treatment Centre | |
| Wodonga, Victoria, Australia, 3690 | |
| Royal Women's Hospital | |
| Carlton, Victoria, Australia, 3053 | |
| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 1 | |
| Waikato Hospital | |
| Hamilton, New Zealand, 2020 | |
| Wellington Cancer Centre | |
| Wellington, New Zealand, 6039 | |
| United Kingdom, England | |
| Airedale General Hospital | |
| Keighley, England, United Kingdom, BD20 6TD | |
| Alexandra Healthcare NHS | |
| Redditch, Worcestershire, England, United Kingdom, B98 7UB | |
| Birmingham Heartlands Hospital | |
| Birmingham, England, United Kingdom, B9 5SS | |
| Blackpool Victoria Hospital | |
| Blackpool, England, United Kingdom, FY3 8NR | |
| Bradford Royal Infirmary | |
| Bradford, England, United Kingdom, BD9 6RJ | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Broomfield Hospital | |
| Broomfield, England, United Kingdom, CM1 7ET | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Hammersmith Hospital | |
| London, England, United Kingdom, W12 OHS | |
| Christie Hospital | |
| Manchester, England, United Kingdom, M20 4BX | |
| Clatterbridge Centre for Oncology | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Dorset County Hospital | |
| Dorchester, England, United Kingdom, DT1 2JY | |
| Essex County Hospital | |
| Colchester, England, United Kingdom, C03 3NB | |
| Furness General Hospital | |
| Barrow in Furness, England, United Kingdom, LA14 4LF | |
| George Eliot Hospital | |
| Nuneaton, England, United Kingdom, CV10 7DJ | |
| Gloucestershire Royal Hospital | |
| Gloucester, England, United Kingdom, GL1 3NN | |
| Guy's Hospital | |
| London, England, United Kingdom, SE1 9RT | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Hereford Hospitals NHS Trust | |
| Hereford, England, United Kingdom, HR1 2ER | |
| Huddersfield Royal Infirmary | |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Ipswich Hospital | |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Kings Mill Hospital | |
| Nottinghamshire, England, United Kingdom, NG17 4JL | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Liverpool Women's Hospital | |
| Liverpool, England, United Kingdom, LV8 7SS | |
| Mid Kent Oncology Centre at Maidstone Hospital | |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Northampton General Hospital NHS Trust | |
| Northampton, England, United Kingdom, NN1 5BD | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Southend University Hospital NHS Foundation Trust | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Queen's Hospital | |
| Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
| Rosemere Cancer Centre at Royal Preston Hospital | |
| Preston, England, United Kingdom, PR2 9HT | |
| Royal Blackburn Hospital | |
| Blackburn, England, United Kingdom, BB2 3HH | |
| Royal Lancaster Infirmary | |
| Lancaster, England, United Kingdom, LA1 4RP | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| Russells Hall Hospital | |
| Dudley, England, United Kingdom, DY1 2HQ | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| South Warwickshire Hospital | |
| Warwick, Warwickshire, England, United Kingdom, CV34 5BJ | |
| Queen Elizabeth The Queen Mother Hospital | |
| Margate, England, United Kingdom, CT9 4AN | |
| St. Georges, University of London | |
| London, England, United Kingdom, SW17 0QT | |
| Sussex Cancer Centre at Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Taunton and Somerset Hospital | |
| Taunton Somerset, England, United Kingdom, TA1 5DA | |
| University College of London Hospitals | |
| London, England, United Kingdom, NW1 2PG | |
| Walsgrave Hospital | |
| Coventry, England, United Kingdom, CV2 2DX | |
| Weston General Hospital | |
| Weston-super-Mare, England, United Kingdom, BS23 4TQ | |
| Yeovil District Hospital | |
| Yeovil - Somerset, England, United Kingdom, BA21 4AT | |
| Whiston Hospital | |
| Prescot Merseyside, England, United Kingdom, L35 5DR | |
| Worcester Royal Hospital | |
| Worcester, England, United Kingdom, WR5 1DD | |
| Worthing Hospital | |
| Worthing, England, United Kingdom, BN11 2DH | |
| Wexham Park Hospital | |
| Slough, Berkshire, England, United Kingdom, SL2 4HL | |
| United Kingdom, Northern Ireland | |
| Centre for Cancer Research and Cell Biology at Queen's University Belfast | |
| Belfast, Northern Ireland, United Kingdom, BT9 7BL | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Dumfries & Galloway Royal Infirmary | |
| Dumfries, Scotland, United Kingdom, DG1 4AP | |
| Edinburgh Cancer Centre at Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XR | |
| Gartnavel General Hospital | |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Ninewells Hospital | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Raigmore Hospital | |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| United Kingdom, Wales | |
| South West Wales Cancer Institute | |
| Swansea, Wales, United Kingdom, SA2 8QA | |
| Velindre Cancer Center at Velindre Hospital | |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| West Wales General Hospital | |
| Carmarthen, Wales, United Kingdom, SA31 2AF | |
| Ysbyty Gwynedd | |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Study Chair: | Stanley B. Kaye, MD, FRCP | Royal Marsden - Surrey |
More Information
| Study ID Numbers: | CDR0000396778, SCOTTISH-SCOTROC-4, EU-20402 |
| Study First Received: | December 8, 2004 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098878 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
|
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions |
Fallopian Tube Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |