A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
N/A
N/A
Male
Testicular Germ Cell Tumor
Trial Information
A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Diagnostic
Principal Investigator
Gordon J.S. Rustin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000066440
NCT ID:
NCT00003420
Start Date:
July 1997
Completion Date:
Related Keywords:
- Testicular Germ Cell Tumor
- stage I malignant testicular germ cell tumor
- testicular teratoma
- Testicular Neoplasms
- Neoplasms, Germ Cell and Embryonal
Name | Location |
|---|
