CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
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|ClinicalTrials.gov Identifier: NCT00003420|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Testicular Germ Cell Tumor||Procedure: computed tomography||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Official Title:||A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma|
|Study Start Date :||July 1997|
|Actual Study Completion Date :||April 2010|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003420
|Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Study Chair:||Gordon J.S. Rustin, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|