Condition category
Cancer
Date applied
04/07/2007
Date assigned
29/08/2007
Last edited
21/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Johnathan Joffe

ORCID ID

Contact details

Greenlea Oncology Unit
Huddersfield Royal Infirmary
Lindley
Huddersfield
West Yorkshire
HD3 3EA
United Kingdom
-
jk.joffe@cht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00589537

Protocol/serial number

MRC TE24

Study information

Scientific title

Trial of Imaging and Schedule in Seminoma Testis

Acronym

TRISST

Study hypothesis

To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as a safe and effective alternative to standard CT-based surveillance in the management of stage one seminoma testis patients without evidence of nonseminomatous germ cell tumour (NSGCT) elements.

As of 21/03/2012, the following amendments have been made to the record.
Australia, Canada and New Zealand have been removed from the countries of recruitment.
Anticipated end date has been modified from 01/11/2016 to 31/05/2020.

Ethics approval

Leeds (East) Research Ethics Committee, 26/10/2007, ref: 07/H1306/127

Study design

Open randomised phase III multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Seminoma testis

Intervention

1. Standard surveillance: CT-based, scans at 6, 12, 18, 24, 36, 48 and 60 months
2. CT-based surveillance: reduced schedule: scans at 6, 18, and 36 months
3. MRI-based surveillance: scans at 6, 12, 18, 24, 36, 48 and 60 months
4. MRI-based surveillance: reduced schedule: scans at 6, 18, and 36 months

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Proportion of patients relapsing with Royal Marsden Hospital (RMH) stage IIC or greater disease.

Primary and secondary outcome timepoint measurements will depend partly on recruitment and event rates. Recruitment will be for five years, and final analyses are expected to be nine years after the first patient is randomised. In addition, annual interim analyses will be performed with an independent data monitoring committee.

Secondary outcome measures

Current secondary outcome measure(s) as of 21/03/2012:
1. Mean abdominal mass size at relapse between CT and MRI
2. Time on surveillance before detection of relapse
3. First modality to detect relapse (patient symptom, clinical examination, tumour marker, chest X-ray [CXR], cross sectional image)
4. Extent of relapse according to International Germ Cell Cancer Collaborative Group (IGCCCG) classification (IGCCCG, 1997)
5. Disease free and overall survival according to schedule randomisation and prognostic grouping
6. Prospective evaluation of prognostic factors for relapse of stage I seminoma patients
7. Number of false positive MRIs
8. Resource use and costs

Primary and secondary outcome timepoint measurements will depend partly on recruitment and event rates. Recruitment will be for five years, and final analyses are expected to be nine years after the first patient is randomised. In addition, annual interim analyses will be performed with an independent data monitoring committee.

Previous secondary outcome measure(s):
1. Mean abdominal mass size at relapse between CT and MRI
2. Time on surveillance before detection of relapse
3. First modality to detect relapse (patient symptom, clinical examination, tumour marker, chest X-ray [CXR], cross sectional image)
4. Extent of relapse according to International Germ Cell Cancer Collaborative Group (IGCCCG) classification (IGCCCG, 1997)
5. Disease free and overall survival according to schedule randomisation and prognostic grouping
6. Prospective evaluation of prognostic factors for relapse of stage I seminoma patients

Primary and secondary outcome timepoint measurements will depend partly on recruitment and event rates. Recruitment will be for five years, and final analyses are expected to be nine years after the first patient is randomised. In addition, annual interim analyses will be performed with an independent data monitoring committee.

Overall trial start date

01/11/2007

Overall trial end date

31/05/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 31/03/2011:
1. Histologically proven seminoma of the testis without evidence of NSGCT elements
2. Clinical stage I on the basis of clinical examination and CT scan of the chest, abdomen and pelvis. This CT scan should have been performed no more than 8 weeks before randomisation
3. No planned adjuvant therapy
4. Normal serum alphafetoprotein (AFP) post-orchidectomy and not known to be raised pre-orchidectomy
5. Normal serum beta-human chorionic gonadotropin (β-HCG) at randomisation (may have been raised pre-orchidectomy)
6. Patient written, informed consent
7. Patients must be able to attend for regular surveillance
8. The interval between orchidectomy and randomisation should not normally exceed 8 weeks (although up to 10 weeks is acceptable in exceptional circumstances following discussion with the trial team)
9. Patients must be at least 16 years old

Previous inclusion criteria:
1. Histologically proven seminoma of the testis without evidence of NSGCT elements
2. Clinical stage one on the basis of clinical examination and CT scan of the chest, abdomen and pelvis
3. No planned adjuvant therapy
4. Normal serum alphafetoprotein (AFP) pre-orchidectomy and at randomisation
5. Normal serum beta-human chorionic gonadotropin (β-HCG) at randomisation (may have been raised pre-orchidectomy)
6. Patient written, informed consent
7. Patient must be able to attend for regular surveillance
8. The interval between orchidectomy and registration should not exceed eight weeks

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

660

Participant exclusion criteria

Current exclusion criteria as of 31/03/2011:
1. Co-existent or previously treated malignancy within 10 years, with the only exceptions being (i) successfully treated non-melanoma skin cancer or, (ii) RMH stage I germ cell tumour of the contralateral testis diagnosed more than 5 years earlier and managed by surveillance
2. Inability for any reason to comply with the trial investigations or follow-up schedules
3. Any contra-indication to MRI, for example, ferrous metal implants of any type, cardiac pacemaker or defibrillators, or history of injury by metal fragments
4. Spermatocytic seminomas

Previous exclusion criteria:
1. Co-existent or previously treated malignancy within ten years other than successfully treated non-melanoma skin cancer
2. Inability for any reason to comply with the trial investigations or follow-up schedules
3. Any contra-indication to magnetic resonance imaging, for example ferrous metal implants of any type, cardiac pacemaker or defibrillators, or history of injury by metal fragments

Recruitment start date

01/11/2007

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Huddersfield Royal Infirmary
West Yorkshire
HD3 3EA
United Kingdom

Trial participating centre

35 other centres
-
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

2nd Floor David Phillips Building
Polaris House
North Star Avenue
Swindon
SN2 1FL
United Kingdom
+44 (0)20 7670 4625
iv@centre-london.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C17084/A8690)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2012 management practices in: www.ncbi.nlm.nih.gov/pubmed/21955594

Publication citations

  1. Management practices

    Cafferty FH, Gabe R, Huddart RA, Rustin G, Williams MP, Stenning SP, Bara A, Bathia R, Freeman SC, Alder L, Joffe JK, UK management practices in stage I seminoma and the Medical Research Council Trial of Imaging and Schedule in Seminoma Testis managed with surveillance., Clin Oncol (R Coll Radiol), 2012, 24, 1, 25-29, doi: 10.1016/j.clon.2011.09.005.

Additional files

Editorial Notes