Testicular Germ Cell Tumor Clinical Trial
Official title:
Trial of Imaging and Schedule in Seminoma Testis
RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not
yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.
PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan
schedules in patients with stage I seminoma of the testicle.
OBJECTIVES:
- To assess whether a reduced computed tomography (CT) schedule or magnetic resonance
imaging (MRI) could be used as safe and effective alternatives to standard CT-based
surveillance in the management of patients with stage I seminoma of the testis.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.
- Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum*
at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
- Arm II: Patients undergo CT scan of the abdomen/retroperitoneum* at 6, 18, and 36
months in the absence of disease progression.
- Arm III: Patients undergo magnetic resonance imaging (MRI) of the
abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of
disease progression.
- Arm IV: Patients undergo MRI of the abdomen/retroperitoneum* at 6, 18, and 36 months in
the absence of disease progression.
NOTE: *Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging
of the pelvis.
Patients complete questionnaires at baseline and periodically during study to assess
health-related quality of life; utilization and cost of healthcare services (including the
cost of CT- or MRI-based surveillance and the management of any recurrence); and
acceptability of allocated scanning schedule.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every
6 months for 3 years.
;
Allocation: Randomized, Primary Purpose: Diagnostic
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