Testicular Germ Cell Tumor
Conditions
Keywords
stage I malignant testicular germ cell tumor, testicular teratoma
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.
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.
Interventions
PROCEDUREcomputed tomography
Sponsors
Medical Research Council
Study design
Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion 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
Countries
United Kingdom
Outcome results
None listed