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

Testicular Germ Cell Tumor Clinical Trial

Official title:

Trial of Imaging and Schedule in Seminoma Testis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00589537
• Other study ID #: MRC-NCRI-TRISST-TE24
• Secondary ID: CDR0000574037EU-
• Status: Recruiting
• Phase: Phase 3
• First received: December 25, 2007
• Last updated: August 6, 2013
• Start date: March 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Seminoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• computed tomography

• magnetic resonance imaging

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Centre for Cancer Research and Cell Biology at Queen's University Belfast	Belfast	Northern Ireland
United Kingdom	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	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
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	Charing Cross Hospital	London	England
United Kingdom	UCL Cancer Institute	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Mid Kent Oncology Centre at Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Churchill Hospital	Oxford	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Yeovil District Hospital	Yeovil	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease			No
Secondary	Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)			No
Secondary	Time on surveillance before detection of relapse			No
Secondary	Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)			No
Secondary	Extent of relapse according to International Germ Cell Cancer Collaborative Group classification			No
Secondary	Disease-free survival			No
Secondary	Overall survival			No
Secondary	Prospective evaluation of prognostic factors for relapse			No
Secondary	Number of false positive MRIs			No
Secondary	Resource use and costs			No