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Phase II/III Randomized Pilot Study of the Timing of Surgery and Chemotherapy in Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III, Phase II | Treatment | Active | Adult | RCOG-MRC-CHORUS
EU-20350, ISRCTN74802813, NCT00075712 |
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.
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 Chemotherapy - See Disease Characteristics
Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal 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 150Approximately 100-150 patients will be accrued for this study within 18 months. Outcomes Primary Outcome(s)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 | | | |
Trial Sites
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| United Kingdom |
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| England |
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Aylesbury-Buckinghamshire |
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| | | | | Stoke Mandeville Hospital |
| | | Damian Eustace, MD | |
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Barnstaple |
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| | | North Devon District Hospital |
| | | Mark Napier, MD | |
| | Email:
mark.napier@ndevon.swest.nhs.uk |
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Bath |
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| | | Royal United Hospital |
| | | Edward Gilby, MD | |
| | Email:
Ed.Gilby@btinternet.com |
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Blackpool |
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| | | Blackpool Victoria Hospital |
| | | Andrew Hindley, MD | |
| | Email:
andrew.hindley@lthtr.nhs.uk |
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Bradford |
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| | | Bradford Royal Infirmary |
| | | Chris Bradley, MD | |
| | Email:
chris.bradley@bradfordhospitals.nhs.uk |
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Brighton |
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| | | Sussex Cancer Centre at Royal Sussex County Hospital |
| | | Andrew Fish, MD | | Ph: | 44-12-7369-6955 ext. 4271 | | |
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Broomfield |
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| | | Broomfield Hospital |
| | | Saad Tahir, MD | |
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Carlisle |
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| | | Cumberland Infirmary |
| | | Alberto Lopes, MD | |
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Cheltenham |
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| | | Gloucestershire Oncology Centre at Cheltenham General Hospital |
| | | Robert Gornall, MD | |
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Colchester |
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| | | Essex County Hospital |
| | | Alan Lamont, MD | |
| | Email:
alan.lamont@essexrivers.nhs.uk |
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Coventry |
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| | | Walsgrave Hospital |
| | | L. J. Santa-Cassia, MD | |
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Derby |
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| | | Derby City General Hospital |
| | | Anish Bali, MD | |
| | | Derbyshire Royal Infirmary |
| | | Anish Bali, MD | |
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Edgbaston |
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| | | Birmingham Women's Hospital |
| | | David Luesley | |
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Exeter |
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| | | Royal Devon and Exeter Hospital |
| | | Anne Hong, MD | |
| | Email:
anne.hong@rdeft.nhs.uk |
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Frimley |
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| | | Frimley Park Hospital |
| | | Gareth Beynon, MD | |
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Gateshead |
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| | | Queen Elizabeth Hospital |
| | | Alberto Lopes, MD | |
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Guildford |
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| | | St. Luke's Cancer Centre at Royal Surrey County Hospital |
| | | Hilary Thomas, MD | |
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Hereford |
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| | | Hereford Hospitals NHS Trust |
| | | Audrey Cook, MD | |
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Hull |
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| | | Princess Royal Hospital at Hull and East Yorkshire NHS Trust |
| | | David Poole, MD | |
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Ipswich |
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| | | Ipswich Hospital |
| | | Jamey Morgan, MBBS, FRCR, MRCP | |
| | Email:
Jamie.Morgan@ipswichhospital.nhs.uk |
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Lancaster |
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| | | Royal Lancaster Infirmary |
| | | Geraldine Skailes, MD | |
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Leeds |
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| | | Leeds Cancer Centre at St. James's University Hospital |
| | | Tim Perren, MD | |
| | Email:
t.j.perren@leeds.ac.uk |
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Leicester |
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| | | Leicester General Hospital |
| | | Philip Kirwan, MD | |
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Lincoln |
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| | | Lincoln County Hospital |
| | | Martin Lamb, MD | |
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Liverpool |
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| | | Liverpool Women's Hospital |
| | | Jonathan Herod, MD | |
| | Email:
jonathan.herod@lwh.nhs.uk |
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London |
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| | | Barts and the London School of Medicine |
| | | Karina Reynolds | | Ph: | 44-20-7377-7000 ext 2321 | | |
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| | | Hammersmith Hospital |
| | | Vicky Hird, MD | |
| | | Medical Research Council Clinical Trials Unit |
| | | Sarah Wheeler | |
| | | Royal Marsden - London |
| | | Thomas Ind, MD | |
| | | Saint Bartholomew's Hospital |
| | | Christopher Gallagher, MD | |
| | Email:
chris.gallagher@bartsandthelondon.nhs.uk |
| | | St. George's Hospital |
| | | Fiona Lofts, MD | |
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Manchester |
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| | | Christie Hospital |
| | | Gordon Jayson, MD | |
| | Email:
gordon.jayson@christie-tr.nwest.nhs.uk |
| | | St. Mary's Hospital |
| | | Henry Kitchener, MD | |
| | | Wythenshawe Hospital |
| | | Rebecca Faulkner, MD | |
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Merseyside |
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| | | Clatterbridge Centre for Oncology |
| | | John Green, MD | |
| | Email:
john.green@ccotrust.nhs.uk |
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Middlesbrough |
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| | | James Cook University Hospital |
| | | Jeremy Twigg, MD | |
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Milton Keynes |
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| | | Milton Keynes General Hospital |
| | | Christopher Lynch, MD, FRCS, FRCOG | |
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Northampton |
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| | | Northampton General Hospital NHS Trust |
| | | Alistar Duncan, MD | |
| | Email:
alistar.duncan@ngh.nhs.uk |
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Norwich |
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| | | Norfolk and Norwich University Hospital |
| | | J. Nieto, MD | |
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Oxford |
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| | | Oxford Radcliffe Hospital |
| | | Sean Kehoe | |
| | Email:
sean.kehoe@obs-gyn.ox.ac.uk |
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Plymouth |
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| | | Derriford Hospital |
| | | Dennis Yiannakis, MD | |
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Poole Dorset |
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| | Richard Osborne, MD, FRCP | |
| | | | Dorset Cancer Centre |
| | | Richard Henry, MD | |
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Portsmouth Hants |
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| | | Portsmouth Oncology Centre at Saint Mary's Hospital |
| | | Patrick Hogston, MD | | Ph: | 44-23-9228-6000 ext. 3521 | | |
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Prescot Merseyside |
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| | | Whiston Hospital |
| | | Graham Cawdell, MD | |
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Preston |
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| | | Rosemere Cancer Centre at Royal Preston Hospital |
| | | Andrew Hindley, MD | |
| | Email:
andrew.hindley@lthtr.nhs.uk |
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Romford |
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| | | Oldchurch Hospital |
| | | Mary Quigley, MD, FRCR | |
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Sheffield |
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| | | Cancer Research Centre at Weston Park Hospital |
| | | Alan Gillespie, MD | |
| | | Royal Hallamshire Hospital |
| | | Alan Gillespie, MD | |
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Shrewsbury |
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| | | Royal Shrewsbury Hospital |
| | | Saif Awwad, MD | |
| | Email:
saif.awwad@sath.nhs.uk |
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Slough, Berkshire |
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| | | Wexham Park Hospital |
| | | Marcia Hall, MD | |
| | Email:
marcia.hall@nhs.net.uk |
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Stafford |
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| | | Staffordshire General Hospital |
| | | Kirk Chin, MD | |
| | Email:
kirk.chin@msgh-tr.wmids.nhs.uk |
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Stoke-On-Trent |
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| | | University Hospital of North Staffordshire |
| | | Charles Redman, MD | |
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Surrey |
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| | | St. Peter's Hospital |
| | | Anil Tailor, MD | |
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Swindon |
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| | | Great Western Hospital |
| | | John Cullimore, MD | |
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Taunton Somerset |
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| | | Taunton and Somerset Hospital |
| | | Orla McNally, MD | |
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Torquay |
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| | | Torbay Hospital |
| | | Nigel Bailey, MD | |
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Walsall |
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| | | Walsall Manor Hospital |
| | | A. C. Head, MD | | Ph: | 44-1922-721-172 ext. 7738 | | |
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West Midlands |
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| | | Good Hope Hospital |
| | | Cath Finn, MD | |
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Westcliff-On-Sea |
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| | | Southend University Hospital NHS Foundation Trust |
| | | Krishnawamy Madhavan, MD | |
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Yeovil |
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| | | Yeovil District Hospital |
| | | J. Giles, MD | |
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| Northern Ireland |
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Belfast |
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| | | | Centre for Cancer Research and Cell Biology at Queen's University Belfast |
| | | Stephen Dobbs | |
| | Email:
stephen.dobbs@bch.n-i.nhs.uk |
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| Scotland |
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Aberdeen |
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| | | | Aberdeen Royal Infirmary |
| | | David Parkin | |
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Dundee |
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| | | Ninewells Hospital |
| | | Michelle Ferguson, MD | |
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Inverness |
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| | | Raigmore Hospital |
| | | Carol MacGregor, MD | |
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| Wales |
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Bangor |
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| | | | Ysbyty Gwynedd |
| | | Simon Leeson | |
| | Email:
simon.leeson@nww-tr.wales.nhs.uk |
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Cardiff |
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| | | University Hospital of Wales |
| | | Alan Evans, MD | |
| | | Velindre Cancer Center at Velindre Hospital |
| | | Malcolm Adams, MD | | Ph: | 44-29-2061-5888 ext. 6204 | | |
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Swansea |
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| | | South West Wales Cancer Institute |
| | | Omar Freites, MD | |
| | Email:
omarfreites@hotmail.com |
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Wrexham |
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| | | Wrexham Maelor Hospital |
| | | Philip Toon, MD, FRCOG | |
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| 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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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