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CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy

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. Identifier: NCT00003420
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Imaging procedures such as CT scans help the doctor in detecting cancer or the recurrence of cancer. Increasing the number of times a CT scan is given may improve the ability to detect stage I testicular cancer.

PURPOSE: Randomized clinical trial to determine if there is a different result from two different schedules of CT scans in treating patients with stage I testicular cancer after undergoing orchiectomy.

Condition or disease Intervention/treatment Phase
Testicular Germ Cell Tumor Procedure: computed tomography Not Applicable

Detailed Description:


  • Determine whether there is a difference between two schedules of CT scan surveillance in respect to stage of disease at relapse, survival, the investigation determining relapse, and incidence of second malignancies in patients with stage I testicular teratoma after orchidectomy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence of vascular invasion.

After orchidectomy, patients are randomized into two schedules (arms I and II) of CT scan follow up.

  • Arm I: Patients repeat chest and abdominal CT scans no later than 3 months after orchidectomy and again at 12 months to confirm that the patient is clear of disease.
  • Arm II: Patients repeat chest and abdominal CT scans at 3, 6, 9, 12, and 24 months after orchidectomy.

Patients are followed monthly for the first year after orchidectomy, then every 2 months for the second year, then every 3 months for the third year, and then every 4-6 months thereafter.

PROJECTED ACCRUAL: There will be 400-900 patients accrued into this study over 3-6 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Primary Purpose: Diagnostic
Official Title: A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
Study Start Date : July 1997
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed nonseminomatous germ cell tumor of the testis Stage I disease:

    • No evidence of metastatic disease on clinical examination
    • Normal chest x-ray
    • Normal chest and abdominal CT scan
    • Normal serum tumor marker (AFP, HCG) after orchidectomy
  • High risk patients should be considered for ongoing studies of adjuvant chemotherapy after orchidectomy, but those choosing not to take this option may enter this study
  • Orchidectomy no greater than 8 weeks prior to randomization into this study



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No other concurrent or prior malignancy except successfully treated nonmelanomatous skin cancer


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics

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 identifier (NCT number): NCT00003420

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United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Sponsors and Collaborators
Medical Research Council
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Study Chair: Gordon J.S. Rustin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
Publications of Results:
Layout table for additonal information Identifier: NCT00003420    
Other Study ID Numbers: CDR0000066440
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2002
Keywords provided by National Cancer Institute (NCI):
stage I malignant testicular germ cell tumor
testicular teratoma
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type