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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003420
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: December 2002

November 1, 1999
December 3, 2013
July 1997
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Complete list of historical versions of study NCT00003420 on ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
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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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
April 2010
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00003420
CDR0000066440, MRC-TE08, EU-98007, ISRCTN56475197
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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