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

August 6, 2013 updated by: Medical Research Council

Trial of Imaging and Schedule in Seminoma Testis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Recruiting
        • Royal Bournemouth Hospital
      • Brighton, England, United Kingdom, BN2 5BF
        • Recruiting
        • Sussex Cancer Centre at Royal Sussex County Hospital
        • Contact:
          • David Bloomfield, MD
          • Phone Number: 44-1273-696-955 ext. 7686
      • Bristol, England, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Contact:
          • Jeremy Braybrooke, MD
          • Phone Number: 44-117-928-2418
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Recruiting
        • Gloucestershire Oncology Centre at Cheltenham General Hospital
        • Contact:
      • Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
        • Recruiting
        • Huddersfield Royal Infirmary
        • Contact:
      • Leeds, England, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
      • Lincoln, England, United Kingdom, LN2 5QY
        • Recruiting
        • Lincoln County Hospital
        • Contact:
          • Thiagarajan Sreenivasant
          • Phone Number: 44-1522-572-203
      • London, England, United Kingdom, NW3 2QG
        • Recruiting
        • UCL Cancer Institute
        • Contact:
          • Tim Meyer, MD, BSc, MRCP, PhD
          • Phone Number: 44-207-679-6731
      • London, England, United Kingdom, WIT 3AA
        • Recruiting
        • University College of London Hospitals
        • Contact:
      • London, England, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital
        • Contact:
          • Philip Savage, MD
          • Phone Number: 44-20-8846-1419
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Recruiting
        • Mid Kent Oncology Centre at Maidstone Hospital
      • Manchester, England, United Kingdom, M20 4BX
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • Recruiting
        • James Cook University Hospital
        • Contact:
          • Adrian Rathmell, MD
          • Phone Number: 44-1642-854-750
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Recruiting
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
        • Contact:
          • Rhona McMenemin
          • Phone Number: 44-191-256-3588
      • Northampton, England, United Kingdom, NN1 5BD
        • Recruiting
        • Northampton General Hospital
        • Contact:
      • Northwood, England, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
        • Contact:
          • Gordon J.S. Rustin, MD
          • Phone Number: 44-1923-844-389
          • Email: grustin@nhs.net
      • Nottingham, England, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Contact:
          • Michael Sokal
          • Phone Number: 44-115-969-1169 ext. 57300
      • Oxford, England, United Kingdom, OX3 7LJ
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Andrew Protheroe, MD
          • Phone Number: 44-186-522-6183
      • Reading, England, United Kingdom, RG1 5AN
        • Recruiting
        • Berkshire Cancer Centre at Royal Berkshire Hospital
        • Contact:
          • Paul Rogers, MD
          • Phone Number: 44-118-987-7688
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Recruiting
        • Cancer Research Centre at Weston Park Hospital
        • Contact:
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
      • Yeovil, England, United Kingdom, BA21 4AT
        • Recruiting
        • Yeovil District Hospital
        • Contact:
          • Chris Parker
          • Phone Number: 44-1935-384-345
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7BL
        • Recruiting
        • Centre for Cancer Research and Cell Biology at Queen's University Belfast
        • Contact:
          • Seamus McAleer
          • Phone Number: 44-28-9032-9241
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Glasgow, Scotland, United Kingdom, G11 6NT
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Center at Velindre Hospital
        • Contact:
          • Jim Barber, MD
          • Phone Number: 44-29-2061-5888
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Recruiting
        • Glan Clwyd Hospital
        • Contact:
          • Audrey Champion
          • Phone Number: 44-1745-534-432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease

Secondary Outcome Measures

Outcome Measure
Overall survival
Disease-free survival
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
Prospective evaluation of prognostic factors for relapse
Number of false positive MRIs
Resource use and costs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Study Chair: Johnathan Joffe, MD, Huddersfield Royal Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

December 25, 2007

First Submitted That Met QC Criteria

December 25, 2007

First Posted (ESTIMATE)

January 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-NCRI-TRISST-TE24
  • CDR0000574037 (REGISTRY: PDQ (Physician Data Query))
  • EU-20771
  • ISRCTN65987321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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