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| ID | Type | Description | Link |
|---|---|---|---|
| MRC-TE08 | |||
| EU-98007 | |||
| ISRCTN56475197 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography | Procedure |
DISEASE CHARACTERISTICS:
Histologically confirmed nonseminomatous germ cell tumor of the testis Stage I disease:
High risk patients should be considered for ongoing studies of adjuvant chemotherapy after orchidectomy, but those choosing not to take this option may enter this study
Orchidectomy no greater than 8 weeks prior to randomization into this study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon J.S. Rustin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Vernon Hospital | Northwood | England | HA6 2RN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17416851 | Result | 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. doi: 10.1200/JCO.2006.08.4889. | |
| Result | 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. |
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| ID | Term |
|---|---|
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| C562472 | Teratoma, Testicular |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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| D014565 |
| Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |