Testicular Germ Cell Tumor
Conditions
Keywords
testicular seminoma, stage I malignant testicular germ cell tumor
Brief summary
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.
Detailed 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.
Interventions
OTHERquestionnaire administration
PROCEDUREcomputed tomography
PROCEDUREmagnetic resonance imaging
PROCEDUREquality-of-life assessment
Sponsors
Medical Research Council
Study design
Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Time on surveillance before detection of relapse | — |
| Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image) | — |
| Extent of relapse according to International Germ Cell Cancer Collaborative Group classification | — |
| Disease-free survival | — |
| Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) | — |
| Prospective evaluation of prognostic factors for relapse | — |
| Number of false positive MRIs | — |
| Resource use and costs | — |
| Overall survival | — |
Countries
United Kingdom
Outcome results
None listed