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| Sponsored by: |
Medical Research Council |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003420 |
Purpose
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 | Intervention |
|
Testicular Germ Cell Tumor |
Procedure: computed tomography |
| MedlinePlus related topics: | CT Scans Cancer Nuclear Scans Testicular Cancer |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Active Control |
| Official Title: | A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma |
| Estimated Enrollment: | 900 |
| Study Start Date: | July 1997 |
OBJECTIVES:
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.
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.
Eligibility
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed nonseminomatous germ cell tumor of the testis Stage I disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United Kingdom, England | |||||
| Mount Vernon Hospital | |||||
| Northwood, England, United Kingdom, HA6 2RN | |||||
| Medical Research Council |
| Study Chair: | Gordon J.S. Rustin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Rustin GJ, Mead GM, Stenning SP, Vasey PA, Aass N, Huddart RA, Sokal MP, Joffe JK, Harland SJ, Kirk SJ; National Cancer Research Institute Testis Cancer Clinical Studies Group. Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group. J Clin Oncol. 2007 Apr 10;25(11):1310-5.
  |
| Mead GM, Rustin GJ, Stenning SP, et al.: Medical Research Council trial of 2 versus 5 CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis. [Abstract] J Clin Oncol 24 (Suppl 18): A-4519, 221s, 2006. |
| Study ID Numbers: | CDR0000066440, MRC-TE08, EU-98007, ISRCTN56475197 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003420 |
| Health Authority: | United States: Federal Government |
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