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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00589537 |
RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.
PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.
Condition | Intervention | Phase |
---|---|---|
Testicular Germ Cell Tumor |
Other: questionnaire administration Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized |
Official Title: | Trial of Imaging and Schedule in Seminoma Testis |
Estimated Enrollment: | 660 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.
NOTE: *Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis.
Patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of CT- or MRI-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed seminoma of the testis
Has undergone orchidectomy within the past 8 weeks
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Michael Williams, MD 44-122-321-7020 michael.williams@addenbrookes.nhs.uk | |
Berkshire Cancer Centre at Royal Berkshire Hospital | Recruiting |
Reading, England, United Kingdom, RG1 5AN | |
Contact: Paul Rogers, MD 44-118-987-7688 | |
Bristol Haematology and Oncology Centre | Recruiting |
Bristol, England, United Kingdom, BS2 8ED | |
Contact: Jeremy Braybrooke, MD 44-117-928-2418 | |
Cancer Research Centre at Weston Park Hospital | Recruiting |
Sheffield, England, United Kingdom, S1O 2SJ | |
Contact: Robert E. Coleman, MD, FRCP 44-114-226-5213 r.e.coleman@sheffield.ac.uk | |
Charing Cross Hospital | Recruiting |
London, England, United Kingdom, W6 8RF | |
Contact: Philip Savage, MD 44-20-8846-1419 | |
Cheltenham General Hospital | Recruiting |
Cheltenham, England, United Kingdom, GL53 7AN | |
Contact: J.R. Owen, MD 44-84-5422-4021 roger.owen@glos.nhs.uk | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: John Logue 44-161-446-3407 john.logue@christie-tr.nwest.nhs.uk | |
Mid Kent Oncology Centre at Maidstone Hospital | Recruiting |
Maidstone, England, United Kingdom, ME16 9QQ | |
Contact: Contact Person 44-1622-729-000 | |
Huddersfield Royal Infirmary | Recruiting |
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
Contact: Johnathan Joffe, MD 44-1484-342-150 jk.joffe@cht.nhs.uk | |
James Cook University Hospital | Recruiting |
Middlesbrough, England, United Kingdom, TS4 3BW | |
Contact: Adrian Rathmell, MD 44-1642-854-750 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Contact Person 44-113-206-6400 | |
Leicester Royal Infirmary | Recruiting |
Leicester, England, United Kingdom, LE1 5WW | |
Contact: Albert Benghiat, MD 44-116-258-5081 albert.benghiat@uhl-tr.nhs.uk | |
Lincoln County Hospital | Recruiting |
Lincoln, England, United Kingdom, LN2 5QY | |
Contact: Thiagarajan Sreenivasant 44-1522-572-203 | |
Churchill Hospital | Recruiting |
Oxford, England, United Kingdom, OX3 7LJ | |
Contact: Andrew Protheroe, MD 44-186-522-6183 | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
Northwood, England, United Kingdom, HA6 2RN | |
Contact: Gordon J.S. Rustin, MD 44-1923-844-389 grustin@nhs.net | |
Northampton General Hospital NHS Trust | Recruiting |
Northampton, England, United Kingdom, NN1 5BD | |
Contact: Christine M. Elwell, MD 44-1604-54-5246 christine.elwell@ngh.nhs.uk | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
Contact: Rhona McMenemin 44-191-256-3588 | |
Nottingham City Hospital NHS Trust | Recruiting |
Nottingham, England, United Kingdom, NG5 1PB | |
Contact: Michael Sokal 44-115-969-1169 ext. 57300 | |
UCL Cancer Institute | Recruiting |
London, England, United Kingdom, NW3 2QG | |
Contact: Tim Meyer, MD, BSc, MRCP, PhD 44-207-679-6731 | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Robert A. Huddart, MD 44-20-8661-3457 robert.huddart@icr.ac.uk | |
Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting |
Brighton, England, United Kingdom, BN2 5BF | |
Contact: David Bloomfield, MD 44-1273-696-955 ext. 7686 | |
Royal Bournemouth Hospital NHS Trust | Recruiting |
Bournemouth, England, United Kingdom, BH7 7DW | |
Contact: Tom Geldart 44-1202-726-088 | |
University College of London Hospitals | Recruiting |
London, England, United Kingdom, WIT 3AA | |
Contact: Stephen J. Harland, MD 44-20-7380-9041 stephen.harland@uclh.org | |
Yeovil District Hospital | Recruiting |
Yeovil, England, United Kingdom, BA21 4AT | |
Contact: Chris Parker 44-1935-384-345 | |
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: Seamus McAleer 44-28-9032-9241 | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Contact: Andrew Hutcheon, MD 44-1224-892-997 andrew.hutcheon@arh.grampian.scot.nhs.uk | |
Beatson West of Scotland Cancer Centre | Recruiting |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Contact: Jeff White, MD 44-141-301-7056 jeff.white@northglasgow.scot.nhs.uk | |
United Kingdom, Wales | |
Glan Clwyd Hospital | Recruiting |
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ | |
Contact: Audrey Champion 44-1745-534-432 | |
Velindre Cancer Center at Velindre Hospital | Recruiting |
Cardiff, Wales, United Kingdom, CF14 2TL | |
Contact: Jim Barber, MD 44-29-2061-5888 |
Study Chair: | Johnathan Joffe, MD | Huddersfield Royal Infirmary |
Study ID Numbers: | CDR0000574037, MRC-NCRI-TRISST-TE24, EU-20771, ISRCTN65987321 |
Study First Received: | December 25, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00589537 History of Changes |
Health Authority: | Unspecified |
testicular seminoma stage I malignant testicular germ cell tumor |
Testicular Cancer Neoplasms, Germ Cell and Embryonal Testicular Diseases Seminoma Testicular Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Germinoma Seminoma |