Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Basic Trial Information

Objectives

1. 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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

Approximately 100-150 patients will be accrued for this study within 18 months.

Outcomes

Overall survival at 3 years
Progression-free survival
Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28)

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.

Trial Contact Information

Trial Lead Organizations

Royal College of Obstetricians and Gynecologists

Sean Kehoe, Principal investigator		Ph: 44-1865-857-942 Email: sean.kehoe@obs-gyn.ox.ac.uk

United Kingdom
England
	Aylesbury-Buckinghamshire
	Stoke Mandeville Hospital
		Damian Eustace, MD	Ph:  44-1494-525-512
	Barnstaple
	North Devon District Hospital
		Mark Napier, MD	Ph:  44-1884-821-747
			Email: mark.napier@ndevon.swest.nhs.uk
	Bath
	Royal United Hospital
		Edward Gilby, MD	Ph:  44-1225-824-317
			Email: Ed.Gilby@btinternet.com
	Blackpool
	Blackpool Victoria Hospital
		Andrew Hindley, MD	Ph:  44-177-252-2908
			Email: andrew.hindley@lthtr.nhs.uk
	Bradford
	Bradford Royal Infirmary
		Chris Bradley, MD	Ph:  44-1274-542-200
			Email: chris.bradley@bradfordhospitals.nhs.uk
	Brighton
	Sussex Cancer Centre at Royal Sussex County Hospital
		Andrew Fish, MD	Ph:  44-12-7369-6955 ext. 4271
	Broomfield
	Broomfield Hospital
		Saad Tahir, MD	Ph:  44-124-551-4750
	Carlisle
	Cumberland Infirmary
		Alberto Lopes, MD	Ph:  44-1914-452-597
	Cheltenham
	Gloucestershire Oncology Centre at Cheltenham General Hospital
		Robert Gornall, MD	Ph:  44-8454-224-331
	Colchester
	Essex County Hospital
		Alan Lamont, MD	Ph:  44-1206-744-582
			Email: alan.lamont@essexrivers.nhs.uk
	Coventry
	Walsgrave Hospital
		L. J. Santa-Cassia, MD	Ph:  44-247-696-7382
	Derby
	Derbyshire Royal Infirmary
		Anish Bali, MD	Ph:  44-1332-785-088
	Royal Derby Hospital
		Anish Bali, MD	Ph:  44-1332-785-088
	Edgbaston
	Birmingham Women's Hospital
		David Luesley	Ph:  (414) 0121 623 6833
	Exeter
	Royal Devon and Exeter Hospital
		Anne Hong, MD	Ph:  44-39-240-2118
			Email: anne.hong@rdeft.nhs.uk
	Frimley
	Frimley Park Hospital
		Gareth Beynon, MD	Ph:  44-1276-604-268
	Gateshead
	Queen Elizabeth Hospital
		Alberto Lopes, MD	Ph:  44-1914-452-597
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Hilary Thomas, MD	Ph:  44-1483-406-823
	Hereford
	Hereford Hospitals
		Audrey Cook, MD	Ph:  44-8454-222-871
	Hull
	Princess Royal Hospital at Hull and East Yorkshire NHS Trust
		David Poole, MD	Ph:  44-1482-624-098
	Ipswich
	Ipswich Hospital
		Jamie Morgan, MBBS, FRCR, MRCP	Ph:  44-1473-704-910
			Email: Jamie.Morgan@ipswichhospital.nhs.uk
	Lancaster
	Royal Lancaster Infirmary
		Geraldine Skailes, MD	Ph:  44-1524-583-739
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Tim Perren, MD	Ph:  44-113-206-4670
			Email: t.j.perren@leeds.ac.uk
	Leicester
	Leicester General Hospital
		Philip Kirwan, MD	Ph:  44-116-258-4832
	Lincoln
	Lincoln County Hospital
		Martin Lamb, MD	Ph:  44-1522-573-261
	Liverpool
	Liverpool Women's Hospital
		Jonathan Herod, MD	Ph:  44-151-702-4003
			Email: jonathan.herod@lwh.nhs.uk
	London
	Barts and the London School of Medicine
		Karina Reynolds	Ph:  44-20-7377-7000 ext 2321
	Hammersmith Hospital
		Vicky Hird, MD	Ph:  44-208-383-5295
	Medical Research Council Clinical Trials Unit
		Sarah Wheeler	Ph:  44-207-7670-4759
	Royal Marsden - London
		Thomas Ind, MD	Ph:  44-78-0858-6132
	Saint Bartholomew's Hospital
		Christopher Gallagher, MD	Ph:  44-20-7601-8521
			Email: chris.gallagher@bartsandthelondon.nhs.uk
	St. George's Hospital
		Fiona Lofts, MD	Ph:  44-20-8725-0231
	Manchester
	Christie Hospital
		Gordon Jayson, MD	Ph:  44-161-446-3606
			Email: gordon.jayson@christie-tr.nwest.nhs.uk
	St. Mary's Hospital
		Henry Kitchener, MD	Ph:  44-161-276-6461
	Wythenshawe Hospital
		Rebecca Faulkner, MD	Ph:  44-1612-912-560
	Merseyside
	Clatterbridge Centre for Oncology
		John Green, MD	Ph:  44-151-482-7743
			Email: john.green@ccotrust.nhs.uk
	Middlesbrough
	James Cook University Hospital
		Jeremy Twigg, MD	Ph:  44-1642-282-587
	Milton Keynes
	Milton Keynes General Hospital
		Christopher Lynch, MD, FRCS, FRCOG	Ph:  44-1908-243-218
	Northampton
	Northampton General Hospital
		Alistar Duncan, MD	Ph:  44-1604-544-967
			Email: alistar.duncan@ngh.nhs.uk
	Norwich
	Norfolk and Norwich University Hospital
		J. Nieto, MD	Ph:  44-1603-288-692
	Oxford
	Oxford Radcliffe Hospital
		Sean Kehoe	Ph:  44-1865-857-942
			Email: sean.kehoe@obs-gyn.ox.ac.uk
	Plymouth
	Derriford Hospital
		Dennis Yiannakis, MD	Ph:  44-175-251-7585
	Poole Dorset
	Dorset Cancer Centre
		Richard Henry, MD	Ph:  44-1202-442-532
		Richard Osborne, MD, FRCP	Ph:  44-1-202-448-265
	Portsmouth Hants
	Portsmouth Oncology Centre at Saint Mary's Hospital
		Patrick Hogston, MD	Ph:  44-23-9228-6000 ext. 3521
	Prescot Merseyside
	Whiston Hospital
		Graham Cawdell, MD	Ph:  44-1514-301-680
	Preston
	Rosemere Cancer Centre at Royal Preston Hospital
		Andrew Hindley, MD	Ph:  44-177-252-2908
			Email: andrew.hindley@lthtr.nhs.uk
	Romford
	Oldchurch Hospital
		Mary Quigley, MD, FRCR	Ph:  44-1708-435-231
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Alan Gillespie, MD	Ph:  44-114-226-5000
	Royal Hallamshire Hospital
		Alan Gillespie, MD	Ph:  44-114-271-1900
	Shrewsbury
	Royal Shrewsbury Hospital
		Saif Awwad, MD	Ph:  44-1743-261-103
			Email: saif.awwad@sath.nhs.uk
	Slough, Berkshire
	Wexham Park Hospital
		Marcia Hall, MD	Ph:  44-1753-634-364
			Email: marcia.hall@nhs.net.uk
	Stafford
	Staffordshire General Hospital
		Kirk Chin, MD	Ph:  44-1785-257-731
			Email: kirk.chin@msgh-tr.wmids.nhs.uk
	Stoke-On-Trent
	University Hospital of North Staffordshire
		Charles Redman, MD	Ph:  44-1782-533-460
	Surrey
	St. Peter's Hospital
		Anil Tailor, MD	Ph:  44-1932-722-050
	Swindon
	Great Western Hospital
		John Cullimore, MD	Ph:  44-179-342-6052
	Taunton Somerset
	Taunton and Somerset Hospital
		Orla McNally, MD	Ph:  44-1823-342-562
	Torquay
	Torbay Hospital
		Nigel Bailey, MD	Ph:  44-180-365-5052
	Walsall
	Walsall Manor Hospital
		A. C. Head, MD	Ph:  44-1922-721-172 ext. 7738
	West Midlands
	Good Hope Hospital
		Cath Finn, MD	Ph:  44-121-378-2211
	Westcliff-On-Sea
	Southend University Hospital NHS Foundation Trust
		Krishnawamy Madhavan, MD	Ph:  44-1702-435-555
	Yeovil
	Yeovil District Hospital
		J. Giles, MD	Ph:  44-1935-384-292
Northern Ireland
	Belfast
	Centre for Cancer Research and Cell Biology at Queen's University Belfast
		Stephen Dobbs	Ph:  44-0-28-9026-3533
			Email: stephen.dobbs@bch.n-i.nhs.uk
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		David Parkin	Ph:  44-1224-553-468
	Dundee
	Ninewells Hospital
		Michelle Ferguson, MD	Ph:  44-1382-660-111
	Inverness
	Raigmore Hospital
		Carol MacGregor, MD	Ph:  44-1463-706-083
Wales
	Bangor
	Ysbyty Gwynedd
		Simon Leeson	Ph:  44-1248-384-954
			Email: simon.leeson@nww-tr.wales.nhs.uk
	Cardiff
	University Hospital of Wales
		Alan Evans, MD	Ph:  44-2920-747-747
	Velindre Cancer Center at Velindre Hospital
		Malcolm Adams, MD	Ph:  44-29-2061-5888 ext. 6204
	Swansea
	South West Wales Cancer Institute
		Omar Freites, MD	Ph:  44-1792-285-399
			Email: omarfreites@hotmail.com
	Wrexham
	Wrexham Maelor Hospital
		Philip Toon, MD, FRCOG	Ph:  44-1978-291-100

Registry Information
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
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00075712
Date Submitted to PDQ		2003-12-02
Information Last Verified		2007-05-25

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