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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|