Trial Information

Trial of Imaging and Schedule in Seminoma Testis

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.