A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
computed tomography
Urogenital Diseases+10
+ Genital Diseases
+ Endocrine System Diseases
Diagnostic Study
Summary
Study start date: July 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.900 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location