Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003420
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN56475197 | None | None | None |
| MRC-TE08 | None | None | None |
| EU-98007 | None | None | None |