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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
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   (Child, Adult, Senior)
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
Bournemouth, England, United Kingdom, BH7 7DW
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BF
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Lincoln County Hospital
Lincoln, England, United Kingdom, LN2 5QY
UCL Cancer Institute
London, England, United Kingdom, NW3 2QG
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Northampton General Hospital
Northampton, England, United Kingdom, NN1 5BD
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LJ
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Yeovil District Hospital
Yeovil, England, United Kingdom, BA21 4AT
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT9 7BL
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Johnathan Joffe, MD Huddersfield Royal Infirmary
  More Information

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
Testicular Neoplasms
Seminoma
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Germinoma

ClinicalTrials.gov processed this record on December 07, 2016