A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
A Phase II Single-arm Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
Western University, Canada
30 participants
Jul 17, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria6
- Adult patients (\>18 years) with pure seminoma on radical orchiectomy specimen.
- Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation.
- Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND
- No more than 2 enlarged retroperitoneal lymph nodes, each no more than 3cm in the primary landing zones.
- Suitable for proposed bilateral RPLND template
- 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 Criteria3
- Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection
- Any non-seminoma component on the orchiectomy specimen.
- AFP \>20 at any time point, pre- or post-orchiectomy.
Interventions
Open bilateral nerve-sparing RPLND.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06932458