Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
NCT ID: NCT00589537
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
660 participants
INTERVENTIONAL
2008-03-31
Brief Summary
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PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.
Detailed Description
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* To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as safe and effective alternatives to standard CT-based surveillance in the management of patients with stage I seminoma of the testis.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.
* Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
* Arm II: Patients undergo CT scan of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression.
* Arm III: Patients undergo magnetic resonance imaging (MRI) of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
* Arm IV: Patients undergo MRI of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
DIAGNOSTIC
Interventions
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questionnaire administration
computed tomography
magnetic resonance imaging
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed seminoma of the testis
* Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis
* No evidence of any non-seminoma germ cell tumor elements
* Has undergone orchidectomy within the past 8 weeks
* Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization
* Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy)
* Not planning to undergo adjuvant therapy
PATIENT CHARACTERISTICS:
* Able to attend regular surveillance
* No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer
* No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
16 Years
MALE
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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Johnathan Joffe, MD
Role: STUDY_CHAIR
Huddersfield Royal Infirmary
Locations
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Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
UCL Cancer Institute
London, England, United Kingdom
Charing Cross Hospital
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Countries
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Facility Contacts
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Tom Geldart
Role: primary
David Bloomfield, MD
Role: primary
Jeremy Braybrooke, MD
Role: primary
Michael Williams, MD
Role: primary
J.R. Owen, MD
Role: primary
Johnathan Joffe, MD
Role: primary
Contact Person
Role: primary
Albert Benghiat, MD
Role: primary
Thiagarajan Sreenivasant
Role: primary
Tim Meyer, MD, BSc, MRCP, PhD
Role: primary
Philip Savage, MD
Role: primary
Stephen J. Harland, MD
Role: primary
Contact Person
Role: primary
John Logue
Role: primary
Adrian Rathmell, MD
Role: primary
Rhona McMenemin
Role: primary
Christine M. Elwell, MD
Role: primary
Gordon J.S. Rustin, MD
Role: primary
Michael Sokal
Role: primary
Andrew Protheroe, MD
Role: primary
Paul Rogers, MD
Role: primary
Robert E. Coleman, MD, FRCP
Role: primary
Robert A. Huddart, MD
Role: primary
Chris Parker
Role: primary
Seamus McAleer
Role: primary
Andrew Hutcheon, MD
Role: primary
Jeff White, MD
Role: primary
Jim Barber, MD
Role: primary
Audrey Champion
Role: primary
References
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Joffe JK, Cafferty FH, Murphy L, Rustin GJS, Sohaib SA, Gabe R, Stenning SP, James E, Noor D, Wade S, Schiavone F, Swift S, Dunwoodie E, Hall M, Sharma A, Braybrooke J, Shamash J, Logue J, Taylor HH, Hennig I, White J, Rudman S, Worlding J, Bloomfield D, Faust G, Glen H, Jones R, Seckl M, MacDonald G, Sreenivasan T, Kumar S, Protheroe A, Venkitaraman R, Mazhar D, Coyle V, Highley M, Geldart T, Laing R, Kaplan RS, Huddart RA; TRISST Trial Management Group and Investigators. Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST). J Clin Oncol. 2022 Aug 1;40(22):2468-2478. doi: 10.1200/JCO.21.01199. Epub 2022 Mar 17.
Other Identifiers
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CDR0000574037
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20771
Identifier Type: -
Identifier Source: secondary_id
ISRCTN65987321
Identifier Type: -
Identifier Source: secondary_id
MRC-NCRI-TRISST-TE24
Identifier Type: -
Identifier Source: org_study_id