Status:
RECRUITING
A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
Lead Sponsor:
Western University, Canada
Conditions:
Testicular Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 sem...
Detailed Description
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 sem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06932458
Start Date
July 17 2025
End Date
June 1 2030
Last Update
July 20 2025
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada