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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00589537
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 9, 2008
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Testicular Germ Cell Tumor Other: questionnaire administration Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: quality-of-life assessment Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Primary Purpose: Diagnostic
Official Title: Trial of Imaging and Schedule in Seminoma Testis
Study Start Date : March 2008
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease

Secondary Outcome Measures :
  1. Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)
  2. Time on surveillance before detection of relapse
  3. Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)
  4. Extent of relapse according to International Germ Cell Cancer Collaborative Group classification
  5. Disease-free survival
  6. Overall survival
  7. Prospective evaluation of prognostic factors for relapse
  8. Number of false positive MRIs
  9. Resource use and costs

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589537


Locations
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Sponsors and Collaborators
Medical Research Council
Investigators
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Study Chair: Johnathan Joffe, MD Huddersfield Royal Infirmary
More Information
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ClinicalTrials.gov Identifier: NCT00589537    
Other Study ID Numbers: MRC-NCRI-TRISST-TE24
CDR0000574037 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20771
ISRCTN65987321
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
testicular seminoma
stage I malignant testicular germ cell tumor
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Seminoma
Neoplasms by Histologic Type
Neoplasms
Germinoma