Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

United Kingdom Research and Innovation (UKRI)

Status and phase: Unknown; Phase 3

Conditions: Testicular Germ Cell Tumor

Treatments: Procedure: magnetic resonance imaging; Other: questionnaire administration; Procedure: computed tomography; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT00589537

CDR0000574037 (Registry Identifier)

ISRCTN65987321

MRC-NCRI-TRISST-TE24

EU-20771

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 660 estimated patients

Sex: Male

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed seminoma of the testis

  • Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis

• No evidence of any non-seminoma germ cell tumor elements

• Has undergone orchidectomy within the past 8 weeks

  • Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization
  • Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy)

• Not planning to undergo adjuvant therapy

PATIENT CHARACTERISTICS:

• Able to attend regular surveillance
• No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer
• No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics