CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma

Conditions
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Testicular Germ Cell Tumor

Intervention / Treatment
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* Procedure: computed tomography


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed nonseminomatous germ cell tumor of the testis Stage I disease: No evidence of metastatic disease on clinical examination Normal chest x-ray Normal chest and abdominal CT scan Normal serum tumor marker (AFP, HCG) after orchidectomy 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: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other concurrent or prior malignancy except successfully treated nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testicular teratoma, stage I malignant testicular germ cell tumor