Trial of Imaging and Schedule in Seminoma Testis

Phase 3

Completed

• Conditions: Seminoma testis; Cancer; Testicular cancer

• Registration Number: ISRCTN65987321
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

2012 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/21955594 management practices 2022 Results article in https://dx.doi.org/10.1200/JCO.21.01199 (added 21/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-29
• Study Completion: 2020-09-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 669

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified