Seminoma testis Cancer Testicular cancer
Conditions
Interventions
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
Sponsors
Medical Research Council (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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 (ß-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 (ß-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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 yea | — |
Countries
England, United Kingdom
Outcome results
None listed