Primary retroperitoneal lymph node dissection for seminoma with limited retroperitoneal lymph node spread

A Phase II Single-arm Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases

This trial will try surgery (retroperitoneal lymph node dissection) to treat men with pure seminoma who have one or two small (≤3 cm) retroperitoneal lymph node metastases and normal tumor markers.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Western University, Canada (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (London, Ontario)
• Trial ID: NCT06932458 on ClinicalTrials.gov

What this trial studies

This single-center Phase 2 interventional trial tests primary bilateral retroperitoneal lymph node dissection (RPLND) in adult men with pure seminoma presenting with limited retroperitoneal nodal disease (no more than two nodes, each ≤3 cm) and normal serum tumor markers. Eligible patients include those with de novo clinical stage II disease or those who relapsed in the retroperitoneum after prior surveillance following orchiectomy. The protocol collects imaging and marker data within defined windows and follows patients for postoperative recurrence, need for adjuvant therapy, and surgical safety outcomes. The goal is to determine oncologic control and complication rates of RPLND as an option that might reduce exposure to chemotherapy or radiotherapy.

Who should consider this trial

Good fit: Adult men (>18 years) with pure seminoma on orchiectomy, either de novo clinical stage II or retroperitoneal relapse after surveillance, with no more than two retroperitoneal nodes ≤3 cm in primary landing zones and normal AFP, HCG, and LDH before surgery are ideal candidates.

Not a fit: Patients with any non-seminoma component, AFP >20 at any time, more extensive nodal disease (more than two nodes or nodes >3 cm), distant metastases, or who are unfit for major abdominal surgery are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could cure some men while avoiding the long-term cardiovascular, secondary cancer, fertility, and other toxicities linked to chemotherapy or radiotherapy.

How similar studies have performed: Several recent prospective single-arm series have reported promising oncologic outcomes for RPLND in limited seminoma, but randomized or long-term comparative evidence remains limited.

Eligibility criteria

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.

Where this trial is running

London, Ontario

• London Health Sciences Centre — London, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Kaydee Connors

Conditions: Testicular Cancer, Seminoma, Retroperitoneal lymph node dissection