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)

November 1, 1999
January 27, 2003
December 4, 2013
July 1997
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Complete list of historical versions of study NCT00003420 on Archive Site
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CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma

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.


  • 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.

Not Applicable
Allocation: Randomized
Primary Purpose: Diagnostic
Testicular Germ Cell Tumor
Procedure: computed tomography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2010
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  • 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:

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Life expectancy:

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


Biologic therapy:

  • Not specified


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Endocrine therapy:

  • Not specified


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  • See Disease Characteristics
Sexes Eligible for Study: Male
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Medical Research Council
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Study Chair: Gordon J.S. Rustin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP