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

Not Applicable

Completed

• Conditions: Testicular Germ Cell Tumor

• Registration Number: NCT00003420
• Lead Sponsor: Medical Research Council

Brief 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.

Study Timeline

• Study Start: 1997-07
• Study First Submitted: 1999-11-01
• Status Verified: 2002-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2010-04
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mount Vernon Hospital; 🇬🇧 Northwood, England, United Kingdom