Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
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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 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Primary Purpose: Diagnostic |
Official Title: | Trial of Imaging and Schedule in Seminoma Testis |
- Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease [ Designated as safety issue: No ]
- Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) [ Designated as safety issue: No ]
- Time on surveillance before detection of relapse [ Designated as safety issue: No ]
- Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image) [ Designated as safety issue: No ]
- Extent of relapse according to International Germ Cell Cancer Collaborative Group classification [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Prospective evaluation of prognostic factors for relapse [ Designated as safety issue: No ]
- Number of false positive MRIs [ Designated as safety issue: No ]
- Resource use and costs [ Designated as safety issue: No ]
Estimated Enrollment: | 660 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
![](https://webarchive.library.unt.edu/web/20121019031344im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
- 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
![](https://webarchive.library.unt.edu/web/20121019031344im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United Kingdom | |
Royal Bournemouth Hospital | Recruiting |
Bournemouth, England, United Kingdom, BH7 7DW | |
Contact: Tom Geldart 44-1202-726-088 | |
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 | |
Bristol Haematology and Oncology Centre | Recruiting |
Bristol, England, United Kingdom, BS2 8ED | |
Contact: Jeremy Braybrooke, MD 44-117-928-2418 | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Michael Williams, MD 44-122-321-7020 michael.williams@addenbrookes.nhs.uk | |
Gloucestershire Oncology Centre at Cheltenham General Hospital | Recruiting |
Cheltenham, England, United Kingdom, GL53 7AN | |
Contact: J.R. Owen, MD 44-84-5422-4021 roger.owen@glos.nhs.uk | |
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 | |
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 | |
UCL Cancer Institute | Recruiting |
London, England, United Kingdom, NW3 2QG | |
Contact: Tim Meyer, MD, BSc, MRCP, PhD 44-207-679-6731 | |
Charing Cross Hospital | Recruiting |
London, England, United Kingdom, W6 8RF | |
Contact: Philip Savage, MD 44-20-8846-1419 | |
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 | |
Mid Kent Oncology Centre at Maidstone Hospital | Recruiting |
Maidstone, England, United Kingdom, ME16 9QQ | |
Contact: Contact Person 44-1622-729-000 | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: John Logue 44-161-446-3407 john.logue@christie-tr.nwest.nhs.uk | |
James Cook University Hospital | Recruiting |
Middlesbrough, England, United Kingdom, TS4 3BW | |
Contact: Adrian Rathmell, MD 44-1642-854-750 | |
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 | |
Northampton General Hospital | Recruiting |
Northampton, England, United Kingdom, NN1 5BD | |
Contact: Christine M. Elwell, MD 44-1604-54-5246 christine.elwell@ngh.nhs.uk | |
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 | |
Nottingham City Hospital | Recruiting |
Nottingham, England, United Kingdom, NG5 1PB | |
Contact: Michael Sokal 44-115-969-1169 ext. 57300 | |
Churchill Hospital | Recruiting |
Oxford, England, United Kingdom, OX3 7LJ | |
Contact: Andrew Protheroe, MD 44-186-522-6183 | |
Berkshire Cancer Centre at Royal Berkshire Hospital | Recruiting |
Reading, England, United Kingdom, RG1 5AN | |
Contact: Paul Rogers, MD 44-118-987-7688 | |
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 | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Robert A. Huddart, MD 44-20-8661-3457 robert.huddart@icr.ac.uk | |
Yeovil District Hospital | Recruiting |
Yeovil, England, United Kingdom, BA21 4AT | |
Contact: Chris Parker 44-1935-384-345 | |
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 | |
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 | |
Velindre Cancer Center at Velindre Hospital | Recruiting |
Cardiff, Wales, United Kingdom, CF14 2TL | |
Contact: Jim Barber, MD 44-29-2061-5888 | |
Glan Clwyd Hospital | Recruiting |
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ | |
Contact: Audrey Champion 44-1745-534-432 |
Study Chair: | Johnathan Joffe, MD | Huddersfield Royal Infirmary |
![](https://webarchive.library.unt.edu/web/20121019031344im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00589537 History of Changes |
Other Study ID Numbers: | CDR0000574037, MRC-NCRI-TRISST-TE24, EU-20771, ISRCTN65987321 |
Study First Received: | December 25, 2007 |
Last Updated: | August 5, 2011 |
Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
testicular seminoma stage I malignant testicular germ cell tumor |
Additional relevant MeSH terms:
Seminoma Neoplasms, Germ Cell and Embryonal Germinoma Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on October 17, 2012