Testicular Germ Cell Tumor Clinical Trial
Official title:
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.
;
Allocation: Randomized, Primary Purpose: Diagnostic
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