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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00003420
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase N/A
Start date July 1997
Completion date April 2010

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