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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorWestern University, Canada

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Retroperitoneal Lymph Node Dissection

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators