Trial of Imaging and Schedule in Seminoma Testis

ISRCTN	ISRCTN65987321
DOI	https://doi.org/10.1186/ISRCTN65987321
ClinicalTrials.gov (NCT)	NCT00589537
Protocol serial number	MRC TE24
Sponsor	Medical Research Council (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C17084/A8690)

Submission date: 04/07/2007
Registration date: 29/08/2007
Last edited: 21/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-to-find-the-best-way-of-using-scans-to-monitor-men-after-treatment-for-seminoma-testicular-cancer

Contact information

Dr Dipa Noor
Scientific

MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn 2nd Floor
London
WC1V 6LJ
United Kingdom

Phone	+44 (0)20 7670-4747
Email	mrcctu.trisst@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Open randomised phase III multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Trial of Imaging and Schedule in Seminoma Testis
Study acronym	TRISST
Study objectives	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(s)	Leeds (East) Research Ethics Committee, 26/10/2007, ref: 07/H1306/127
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	29/09/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	660
Total final enrolment	669
Key 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
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Huddersfield Royal Infirmary

West Yorkshire
HD3 3EA
United Kingdom

35 other centres

-
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The trial data are held at MRC Clinical Trials Unit at UCL which encourages optimal use of data by employing a controlled access approach to data sharing. Requests for data can be made via application to the Trial Steering Committee. Further information on both the approach and the application process can be found here: http://www.ctu.mrc.ac.uk/our_research/datasharing/

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		17/03/2022	21/03/2022	Yes	No
Other publications	management practices	01/02/2012		Yes	No
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/03/2022: Publication reference added.
15/07/2021: The following changes have been made:
1. The trial contact has been updated.
2. The publication and dissemination plan has been added.
3. The intention to publish date has been added.
25/06/2021: The following changes have been made:
1. The plain English summary link has been updated.
2. The overall trial end date has been changed from 31/05/2020 to 29/09/2020.
3. The total final enrolment number has been added.
26/05/2021: Cancer Research UK lay results summary link added to Results (plain English).