NCT00003420

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
PROCEDURE	computed tomography

Timeline

• Start date: 1997-07-01
• Completion: 2010-04-01
• First posted: 2003-01-27
• Last updated: 2013-12-04

Locations

1 site across 1 country: United Kingdom