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Testicular Germ Cell TumorPhase 3NCT00589537

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

A Phase 3 study testing questionnaire administration, computed tomography and magnetic resonance imaging in people with Testicular Germ Cell Tumor, run by Medical Research Council at 29 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older, men only
Conditions the study is for
Testicular Germ Cell Tumor
What is being tested?
questionnaire administration, computed tomography and magnetic resonance imaging
Type of treatment
Surgery or procedure
How many people
660 participants
Where
29 sitesUnited Kingdom
Study dates
Mar 2008to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United Kingdom29 sites, 29 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

    Andrew Hutcheon, MD, 44-1224-892-997, andrew.hutcheon@arh.grampian.scot.nhs.uk

    Recruiting

  • Centre for Cancer Research and Cell Biology at Queen's University Belfast

    Belfast, Northern Ireland, BT9 7BL

    Seamus McAleer, 44-28-9032-9241

    Recruiting

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

    Tom Geldart, 44-1202-726-088

    Recruiting

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BF

    David Bloomfield, MD, 44-1273-696-955 ext. 7686

    Recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

    Jeremy Braybrooke, MD, 44-117-928-2418

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

    Michael Williams, MD, 44-122-321-7020, michael.williams@addenbrookes.nhs.uk

    Recruiting

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

    Jim Barber, MD, 44-29-2061-5888

    Recruiting

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

    J.R. Owen, MD, 44-84-5422-4021, roger.owen@glos.nhs.uk

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G11 6NT

    Jeff White, MD, 44-141-301-7056, jeff.white@northglasgow.scot.nhs.uk

    Recruiting

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

    Johnathan Joffe, MD, 44-1484-342-150, jk.joffe@cht.nhs.uk

    Recruiting

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

    Contact Person, 44-113-206-6400

    Recruiting

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

    Albert Benghiat, MD, 44-116-258-5081, albert.benghiat@uhl-tr.nhs.uk

    Recruiting

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

    Thiagarajan Sreenivasant, 44-1522-572-203

    Recruiting

  • UCL Cancer Institute

    London, England, NW3 2QG

    Tim Meyer, MD, BSc, MRCP, PhD, 44-207-679-6731

    Recruiting

  • Charing Cross Hospital

    London, England, W6 8RF

    Philip Savage, MD, 44-20-8846-1419

    Recruiting

  • University College of London Hospitals

    London, England, WIT 3AA

    Stephen J. Harland, MD, 44-20-7380-9041, stephen.harland@uclh.org

    Recruiting

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England, ME16 9QQ

    Contact Person, 44-1622-729-000

    Recruiting

  • Christie Hospital

    Manchester, England, M20 4BX

    John Logue, 44-161-446-3407, john.logue@christie-tr.nwest.nhs.uk

    Recruiting

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

    Adrian Rathmell, MD, 44-1642-854-750

    Recruiting

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

    Rhona McMenemin, 44-191-256-3588

    Recruiting

  • Northampton General Hospital

    Northampton, England, NN1 5BD

    Christine M. Elwell, MD, 44-1604-54-5246, christine.elwell@ngh.nhs.uk

    Recruiting

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

    Gordon J.S. Rustin, MD, 44-1923-844-389, grustin@nhs.net

    Recruiting

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

    Michael Sokal, 44-115-969-1169 ext. 57300

    Recruiting

  • Churchill Hospital

    Oxford, England, OX3 7LJ

    Andrew Protheroe, MD, 44-186-522-6183

    Recruiting

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

    Paul Rogers, MD, 44-118-987-7688

    Recruiting

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

    Audrey Champion, 44-1745-534-432

    Recruiting

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

    Robert E. Coleman, MD, FRCP, 44-114-226-5213, r.e.coleman@sheffield.ac.uk

    Recruiting

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

    Robert A. Huddart, MD, 44-20-8661-3457, robert.huddart@icr.ac.uk

    Recruiting

  • Yeovil District Hospital

    Yeovil, England, BA21 4AT

    Chris Parker, 44-1935-384-345

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
questionnaire administration, computed tomography, magnetic resonance imaging, quality-of-life assessment
Keywords
testicular seminoma, stage I malignant testicular germ cell tumor
Medical subject headings
Testicular Germ Cell Tumor, Seminoma, Testicular Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaire administrationOther

  • computed tomographyProcedure or surgery

  • magnetic resonance imagingProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease

Secondary outcomes (9)

  1. Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)

  2. Time on surveillance before detection of relapse

  3. Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)

  4. Extent of relapse according to International Germ Cell Cancer Collaborative Group classification

  5. Disease-free survival

  6. Overall survival

  7. Prospective evaluation of prognostic factors for relapse

  8. Number of false positive MRIs

  9. Resource use and costs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00589537
Sponsor's protocol ID
MRC-NCRI-TRISST-TE24
Other IDs
CDR0000574037, EU-20771, ISRCTN65987321
Status last verified
Jul 2009
First submitted
25 Dec 2007
Last updated
7 Aug 2013
Results posted
No

Publications

  • Joffe JK, Cafferty FH, Murphy L, Rustin GJS, Sohaib SA, Gabe R, Stenning SP, James E, Noor D, Wade S, Schiavone F, Swift S, Dunwoodie E, Hall M, Sharma A, Braybrooke J, Shamash J, Logue J, Taylor HH, Hennig I, White J, Rudman S, Worlding J, Bloomfield D, Faust G, Glen H, Jones R, Seckl M, MacDonald G, Sreenivasan T, Kumar S, Protheroe A, Venkitaraman R, Mazhar D, Coyle V, Highley M, Geldart T, Laing R, Kaplan RS, Huddart RA; TRISST Trial Management Group and Investigators. Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST). J Clin Oncol. 2022 Aug 1;40(22):2468-2478. doi: 10.1200/JCO.21.01199. Epub 2022 Mar 17.

    PubMed 35298280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing questionnaire administration, computed tomography and magnetic resonance imaging in people with Testicular Germ Cell Tumor, run by Medical Research Council at 29 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00589537, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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