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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Retroperitoneal Lymph Node Dissection
Procedure/SurgeryOpen bilateral nerve-sparing RPLND.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence Free Survival
2-year RFS (absence of radiological metastases on cross-sectional imaging and normal serum tumour markers).
Secondary outcomes
Complications
Complications post RPLND (Clavein-Dindo)
Length of Stay in hospital
Length of stay in hospital post RPLND
Treatment-Free Survival
Patients avoiding additional treatments for seminoma post RPLND (e.g. chemotherapy / radiotherapy)
Cancer-specific Survival
Percentage of people who have not died from testicular cancer during follow-up
Sponsors and contacts
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