NCT00589537

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

29 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

August 7, 2013

Status Verified

July 1, 2009

Enrollment Period

8.8 years

First QC Date

December 25, 2007

Last Update Submit

August 6, 2013

Conditions

Keywords

testicular seminomastage I malignant testicular germ cell tumor

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (29)

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

RECRUITING

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BF, United Kingdom

RECRUITING

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

RECRUITING

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

RECRUITING

UCL Cancer Institute

London, England, NW3 2QG, United Kingdom

RECRUITING

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

RECRUITING

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

RECRUITING

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

RECRUITING

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

RECRUITING

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

RECRUITING

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

RECRUITING

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

RECRUITING

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

RECRUITING

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

RECRUITING

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

RECRUITING

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

RECRUITING

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

Belfast, Northern Ireland, BT9 7BL, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

RECRUITING

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

RECRUITING

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Testicular Germ Cell TumorSeminomaTesticular Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

GerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Johnathan Joffe, MD

    Huddersfield Royal Infirmary

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 25, 2007

First Posted

January 9, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2016

Last Updated

August 7, 2013

Record last verified: 2009-07

Locations