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| Sponsor: | Royal College of Obstetricians and Gynecologists |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075712 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | 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 |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United Kingdom, England | |
| Barts and the London School of Medicine | Recruiting |
| London, England, United Kingdom, EC1M 6GR | |
| Contact: Karina Reynolds 44-20-7377-7000 ext 2321 | |
| Birmingham Women's Hospital | Recruiting |
| Edgbaston, England, United Kingdom, B15 2TG | |
| Contact: David Luesley (414) 0121 623 6833 | |
| Blackpool Victoria Hospital | Recruiting |
| Blackpool, England, United Kingdom, FY3 8NR | |
| Contact: Andrew C. Hindley, MD 44-177-252-2908 andrew.hindley@lthtr.nhs.uk | |
| Bradford Royal Infirmary | Recruiting |
| Bradford, England, United Kingdom, BD9 6RJ | |
| Contact: Chris Bradley, MD 44-1274-542-200 chris.bradley@bradfordhospitals.nhs.uk | |
| Broomfield Hospital | Recruiting |
| Broomfield, England, United Kingdom, CM1 7ET | |
| Contact: Saad Tahir, MD 44-124-551-4750 | |
| Cancer Research Centre at Weston Park Hospital | Recruiting |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Contact: Alan M. Gillespie, MD 44-114-226-5000 | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: Gordon Jayson, MD 44-161-446-3606 gordon.jayson@christie-tr.nwest.nhs.uk | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: John A. Green, MD 44-151-482-7743 john.green@ccotrust.nhs.uk | |
| Cumberland Infirmary | Recruiting |
| Carlisle, England, United Kingdom, CA2 7HY | |
| Contact: Alberto Lopes, MD 44-1914-452-597 | |
| Derby City General Hospital | Recruiting |
| Derby, England, United Kingdom, DE22 3NE | |
| Contact: Anish Bali, MD 44-1332-785-088 | |
| Derbyshire Royal Infirmary | Recruiting |
| Derby, England, United Kingdom, DE1 2QY | |
| Contact: Anish Bali, MD 44-1332-785-088 | |
| Derriford Hospital | Recruiting |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Contact: Dennis Yiannakis, MD 44-175-251-7585 | |
| Dorset Cancer Centre | Recruiting |
| Poole Dorset, England, United Kingdom, BH15 2JB | |
| Contact: Richard Henry, MD 44-1202-442-532 | |
| Essex County Hospital | Recruiting |
| Colchester, England, United Kingdom, C03 3NB | |
| Contact: Alan Lamont, MD 44-1206-744-582 alan.lamont@essexrivers.nhs.uk | |
| Frimley Park Hospital | Recruiting |
| Frimley, England, United Kingdom, GU16 5UJ | |
| Contact: Gareth Beynon, MD 44-1276-604-268 | |
| Gloucestershire Oncology Centre at Cheltenham General Hospital | Recruiting |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Contact: Robert Gornall, MD 44-8454-224-331 | |
| Good Hope Hospital | Recruiting |
| West Midlands, England, United Kingdom, B75 7RR | |
| Contact: Cath Finn, MD 44-121-378-2211 | |
| Princess Royal Hospital at Hull and East Yorkshire NHS Trust | Recruiting |
| Hull, England, United Kingdom, HU8 9HE | |
| Contact: David Poole, MD 44-1482-624-098 | |
| Hammersmith Hospital | Recruiting |
| London, England, United Kingdom, W12 OHS | |
| Contact: Vicky Hird, MD 44-208-383-5295 | |
| Hereford Hospitals NHS Trust | Recruiting |
| Hereford, England, United Kingdom, HR1 2ER | |
| Contact: Audrey Cook, MD 44-8454-222-871 | |
| Ipswich Hospital | Recruiting |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Contact: Jamey S. Morgan, MBBS, FRCR, MRCP 44-1473-704-910 Jamie.Morgan@ipswichhospital.nhs.uk | |
| James Cook University Hospital | Recruiting |
| Middlesbrough, England, United Kingdom, TS4 3BW | |
| Contact: Jeremy Twigg, MD 44-1642-282-587 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Tim J. Perren, MD 44-113-206-4670 t.j.perren@leeds.ac.uk | |
| Leicester General Hospital | Recruiting |
| Leicester, England, United Kingdom, LE5 4PW | |
| Contact: Philip Kirwan, MD 44-116-258-4832 | |
| Lincoln County Hospital | Recruiting |
| Lincoln, England, United Kingdom, LN2 5QY | |
| Contact: Martin Lamb, MD 44-1522-573-261 | |
| Liverpool Women's Hospital | Recruiting |
| Liverpool, England, United Kingdom, L8 7SS | |
| Contact: Jonathan Herod, MD 44-151-702-4003 jonathan.herod@lwh.nhs.uk | |
| Medical Research Council Clinical Trials Unit | Recruiting |
| London, England, United Kingdom, NW1 2DA | |
| Contact: Sarah Wheeler 44-207-7670-4759 | |
| Milton Keynes General Hospital | Recruiting |
| Milton Keynes, England, United Kingdom, MK6 5LD | |
| Contact: Christopher B. Lynch, MD, FRCS, FRCOG 44-1908-243-218 | |
| Norfolk and Norwich University Hospital | Recruiting |
| Norwich, England, United Kingdom, NR4 7UY | |
| Contact: J. Nieto, MD 44-1603-288-692 | |
| North Devon District Hospital | Recruiting |
| Barnstaple, England, United Kingdom, EX31 4JB | |
| Contact: Mark Napier, MD 44-1884-821-747 mark.napier@ndevon.swest.nhs.uk | |
| Northampton General Hospital NHS Trust | Recruiting |
| Northampton, England, United Kingdom, NN1 5BD | |
| Contact: Alistar R. Duncan, MD 44-1604-544-967 alistar.duncan@ngh.nhs.uk | |
| Oldchurch Hospital | Recruiting |
| Romford, England, United Kingdom, RM7 OBE | |
| Contact: Mary Quigley, MD, FRCR 44-1708-435-231 | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 7LJ | |
| Contact: Sean Kehoe 44-1865-857-942 sean.kehoe@obs-gyn.ox.ac.uk | |
| Portsmouth Oncology Centre at Saint Mary's Hospital | Recruiting |
| Portsmouth Hants, England, United Kingdom, PO3 6AD | |
| Contact: Patrick Hogston, MD 44-23-9228-6000 ext. 3521 | |
| Great Western Hospital | Recruiting |
| Swindon, England, United Kingdom, SN3 6BB | |
| Contact: John Cullimore, MD 44-179-342-6052 | |
| Queen Elizabeth Hospital | Recruiting |
| Gateshead, England, United Kingdom, NE9 6SX | |
| Contact: Alberto Lopes, MD 44-1914-452-597 | |
| Rosemere Cancer Centre at Royal Preston Hospital | Recruiting |
| Preston, England, United Kingdom, PR2 9HT | |
| Contact: Andrew C. Hindley, MD 44-177-252-2908 andrew.hindley@lthtr.nhs.uk | |
| Royal Devon and Exeter Hospital | Recruiting |
| Exeter, England, United Kingdom, EX2 5DW | |
| Contact: Anne Hong, MD 44-39-240-2118 anne.hong@rdeft.nhs.uk | |
| Royal Hallamshire Hospital | Recruiting |
| Sheffield, England, United Kingdom, S1O 2JF | |
| Contact: Alan M. Gillespie, MD 44-114-271-1900 | |
| Royal Lancaster Infirmary | Recruiting |
| Lancaster, England, United Kingdom, LA1 4RP | |
| Contact: Geraldine Skailes, MD 44-1524-583-739 | |
| Royal Marsden - London | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Contact: Thomas Ind, MD 44-78-0858-6132 | |
| Royal Shrewsbury Hospital | Recruiting |
| Shrewsbury, England, United Kingdom, SY3 8XQ | |
| Contact: Saif Awwad, MD 44-1743-261-103 saif.awwad@sath.nhs.uk | |
| Royal United Hospital | Recruiting |
| Bath, England, United Kingdom, BA1 3NG | |
| Contact: Edward Gilby, MD 44-1225-824-317 Ed.Gilby@btinternet.com | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: Christopher J. Gallagher, MD 44-20-7601-8521 chris.gallagher@bartsandthelondon.nhs.uk | |
| Taunton and Somerset Hospital | Recruiting |
| Taunton Somerset, England, United Kingdom, TA1 5DA | |
| Contact: Orla McNally, MD 44-1823-342-562 | |
| St. George's Hospital | Recruiting |
| London, England, United Kingdom, SW17 0QT | |
| Contact: Fiona J. Lofts, MD 44-20-8725-0231 | |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
| Guildford, England, United Kingdom, GU2 7XX | |
| Contact: Hilary Thomas, MD 44-1483-406-823 | |
| St. Mary's Hospital | Recruiting |
| Manchester, England, United Kingdom, M13 0JH | |
| Contact: Henry C. Kitchener, MD 44-161-276-6461 | |
| St. Peter's Hospital | Recruiting |
| Surrey, England, United Kingdom, KT 16 OPZ | |
| Contact: Anil Tailor, MD 44-1932-722-050 | |
| Staffordshire General Hospital | Recruiting |
| Stafford, England, United Kingdom, ST16 3SA | |
| Contact: Kirk Chin, MD 44-1785-257-731 kirk.chin@msgh-tr.wmids.nhs.uk | |
| Stoke Mandeville Hospital | Recruiting |
| Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL | |
| Contact: Damian Eustace, MD 44-1494-525-512 | |
| Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting |
| Brighton, England, United Kingdom, BN2 5BE | |
| Contact: Andrew Fish, MD 44-12-7369-6955 ext. 4271 | |
| Southend University Hospital NHS Foundation Trust | Recruiting |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| Contact: Krishnawamy Madhavan, MD 44-1702-435-555 | |
| Torbay Hospital | Recruiting |
| Torquay, England, United Kingdom, TQ2 7AA | |
| Contact: Nigel Bailey, MD 44-180-365-5052 | |
| University Hospital of North Staffordshire | Recruiting |
| Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
| Contact: Charles W.E. Redman, MD 44-1782-533-460 | |
| Walsall Manor Hospital | Recruiting |
| Walsall, England, United Kingdom, WS2 9PS | |
| Contact: A. C. Head, MD 44-1922-721-172 ext. 7738 | |
| Walsgrave Hospital | Recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Contact: L. J. Santa-Cassia, MD 44-247-696-7382 | |
| Wexham Park Hospital | Recruiting |
| Slough, Berkshire, England, United Kingdom, SL2 4HL | |
| Contact: Marcia Hall, MD 44-1753-634-364 marcia.hall@nhs.net.uk | |
| Whiston Hospital | Recruiting |
| Prescot Merseyside, England, United Kingdom, L35 5DR | |
| Contact: Graham Cawdell, MD 44-1514-301-680 | |
| Wythenshawe Hospital | Recruiting |
| Manchester, England, United Kingdom, M23 9LJ | |
| Contact: Rebecca Faulkner, MD 44-1612-912-560 | |
| Yeovil District Hospital | Recruiting |
| Yeovil, England, United Kingdom, BA21 4AT | |
| Contact: J. Giles, MD 44-1935-384-292 | |
| United Kingdom, Northern Ireland | |
| Centre for Cancer Research and Cell Biology at Queen's University Belfast | Recruiting |
| Belfast, Northern Ireland, United Kingdom, BT9 7BL | |
| Contact: Stephen Dobbs 44-0-28-9026-3533 stephen.dobbs@bch.n-i.nhs.uk | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: David Parkin 44-1224-553-468 | |
| Ninewells Hospital | Recruiting |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Contact: Michelle Ferguson, MD 44-1382-660-111 | |
| Raigmore Hospital | Recruiting |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| Contact: Carol MacGregor, MD 44-1463-706-083 | |
| United Kingdom, Wales | |
| South West Wales Cancer Institute | Recruiting |
| Swansea, Wales, United Kingdom, SA2 8QA | |
| Contact: Omar Freites, MD 44-1792-285-399 omarfreites@hotmail.com | |
| Ysbyty Gwynedd | Recruiting |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Contact: Simon Leeson 44-1248-384-954 simon.leeson@nww-tr.wales.nhs.uk | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Contact: Malcolm Adams, MD 44-29-2061-5888 ext. 6204 | |
| Wrexham Maelor Hospital | Recruiting |
| Wrexham, Wales, United Kingdom, LL13 7TD | |
| Contact: Philip G. Toon, MD, FRCOG 44-1978-291-100 | |
| University Hospital of Wales | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Contact: Alan S. Evans, MD 44-2920-747-747 | |
| Principal Investigator: | Sean Kehoe | Oxford Radcliffe Hospital |
More Information
| Study ID Numbers: | CDR0000347463, RCOG-MRC-CHORUS, EU-20350, ISRCTN74802813 |
| Study First Received: | January 9, 2004 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075712 History of Changes |
| Health Authority: | Unspecified |
|
peritoneal cavity cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female |
Endocrine System Diseases Carboplatin Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |