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Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2007
First Received: January 9, 2004   Last Updated: October 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 3 years [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28) [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2003
Detailed Description:

OBJECTIVES:

  • Determine the feasibility of a randomized trial to determine the impact of the timing of surgery and chemotherapy in patients with newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary surgery, patients receive chemotherapy comprising carboplatin alone or in combination with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo interval debulking surgery after the third course of chemotherapy.
  • Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3 courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6 weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm I.

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
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Clinical and imaging evidence of a pelvic mass with extrapelvic metastases within the past 4 weeks
  • Serum CA 125/CEA ratio > 25
  • Plans to receive carboplatin-based chemotherapy

PATIENT CHARACTERISTICS:

Age

  • Adult

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Considered fit to undergo protocol treatment and follow-up
  • No other prior or concurrent malignancy that would preclude study treatment or comparisons

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075712

  Hide Study Locations
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        
Sponsors and Collaborators
Royal College of Obstetricians and Gynecologists
Investigators
Principal Investigator: Sean Kehoe Oxford Radcliffe Hospital
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
peritoneal cavity cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 25, 2009