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A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases

RecruitingPhase 2Ages 18 Years - anyMaleWestern University, Canada
NCT06932458 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Testicular cancer represents 1% of adult neoplasms and is the most common solid malignancy in young men. At diagnosis, approximately 90% of cases are germ cell tumours (GCT), categorised as either seminoma (55-60%) or non-seminoma types (40-45%). For many years, the management of patients with CS IIA/B seminoma and retroperitoneal lymph node involvement ≤ 3 cm are eligible for treatment with either radiotherapy or chemotherapy Despite high cure rates for CS II seminoma (approximately 90%) with chemotherapy or radiotherapy, concerns persist regarding short and long-term treatment-related toxicities (such as increased risks of cardiovascular disease and secondary malignancies As such, an alternative strategy which has been explored in this study is the role of RPLND for the management of these patients

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult patients (\>18 years) with pure seminoma on radical orchiectomy specimen. 2. Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation. 3. Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND 1. No more than 2 enlarged retroperitoneal lymph nodes, each no more than 3cm in the primary landing zones. 2. Suitable for proposed bilateral RPLND template 4. Serum tumour markers (alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), and lactate dehydrogenase (LDH)) must all be within normal limits within 2 weeks of planned RPLND Exclusion Criteria: 1. Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection 2. Any non-seminoma component on the orchiectomy specimen. 3. AFP \>20 at any time point, pre- or post-orchiectomy.
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What it tests

  • Retroperitoneal Lymph Node Dissection
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Where

1 site
London Health Sciences Centre
London, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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