Recruiting
Phase 2

RPLND

Sponsor:

Western University, Canada

Code:

NCT06932458

Conditions

Testicular Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Retroperitoneal Lymph Node Dissection

Study Details

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 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

Conditions

Testicular Cancer

Study ID

NCT06932458

Start date

Jul 17, 2025

Status verified date

Jul, 2025

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: CS IIA/IIB Seminoma

Patients with relapsed CS I or de novo CS IIA/B with <3cm lymph node in the retroperitoneal lymph node.

Interventions

Retroperitoneal Lymph Node Dissection

Open bilateral nerve-sparing RPLND.

Primary outcome measure

  • Recurrence Free Survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Kaydee Connors

519-685-8500Kaydee.Connors@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Contacts

Kaydee Connors

519-685-8500Kaydee.Connors@lhsc.on.ca

More Information

Sponsor

Western University, Canada

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Keywords

  • Seminoma
  • Retroperitoneal lymph node dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2025-07-20.