Trial of Imaging and Schedule in Seminoma Testis
| ISRCTN | ISRCTN65987321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65987321 |
| ClinicalTrials.gov number | NCT00589537 |
| Secondary identifying numbers | MRC TE24 |
- 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
Contact information
Dr Dipa Noor
Scientific
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 |
|---|---|
| mrcctu.trisst@ucl.ac.uk |
Study information
| Study design | Open randomised phase III multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Trial of Imaging and Schedule in Seminoma Testis |
| Study 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(s) | Leeds (East) Research Ethics Committee, 26/10/2007, ref: 07/H1306/127 |
| 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 |
| Primary outcome measure | 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 study start date | 01/11/2007 |
| Overall study end date | 29/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 660 |
| Total final enrolment | 669 |
| 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 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
- England
- United Kingdom
Study participating centres
Huddersfield Royal Infirmary
West Yorkshire
HD3 3EA
United Kingdom
HD3 3EA
United Kingdom
35 other centres
-
United Kingdom
United Kingdom
Sponsor information
Medical Research Council (UK)
Research council
Research council
2nd Floor David Phillips Building
Polaris House
North Star Avenue
Swindon
SN2 1FL
United Kingdom
| Phone | +44 (0)20 7670 4625 |
|---|---|
| iv@centre-london.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C17084/A8690)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results from the primary analysis and pre-specified secondary analyses will be presented at relevant national/international meetings and will be published in peer-reviewed journals following funder open access requirements. A plain English summary of the results will be distributed to participants and will also be published on the study and funder websites. |
| 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? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Other publications | management practices | 01/02/2012 | Yes | No | |
| Results article | 17/03/2022 | 21/03/2022 | Yes | No |
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).
