Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
- Conditions
- Testicular Germ Cell Tumor
- Registration Number
- NCT00589537
- Lead Sponsor
- Medical Research Council
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 660
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease
- Secondary Outcome Measures
Name Time Method Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) 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 Overall survival Prospective evaluation of prognostic factors for relapse Number of false positive MRIs Resource use and costs
Trial Locations
- Locations (29)
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
UCL Cancer Institute
🇬🇧London, England, United Kingdom
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