Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2009 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00589537
First received: December 25, 2007
Last updated: August 6, 2013
Last verified: July 2009
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589537

Locations
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      
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   
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      
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      
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Johnathan Joffe, MD Huddersfield Royal Infirmary
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00589537     History of Changes
Other Study ID Numbers: MRC-NCRI-TRISST-TE24, CDR0000574037, EU-20771, ISRCTN65987321
Study First Received: December 25, 2007
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
testicular seminoma
stage I malignant testicular germ cell tumor

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Seminoma
Testicular Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Germinoma
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Testicular Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014