ISRCTN65987321已完成3 期
Trial of Imaging and Schedule in Seminoma Testis
Medical Research Council (UK)0 个研究点目标入组 669 人开始时间: 2007年8月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 669
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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