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

July 16, 2025 updated by: Western University, Canada

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 seminoma (55-60%) or non-seminoma types (40-45%). Approximately 20% of men with seminoma present with clinical stage (CS) II disease, characterized by enlarged retroperitoneal lymph nodes without distant metastasis.

For many decades for patients who recur following CS 1 seminoma or present with de novo CS IIA/B seminoma, either radiotherapy (30-36Gy) or chemotherapy (BEPx3, EPx4) has been the mainstay of treatment. Yet, both treatment paradigms carry significant short and long-term treatment-related toxicities. Radiotherapy, when compared to surveillance or surgery alone, has been shown to double the risk of cardiovascular disease and secondary malignancies (with an incidence of 2-3%). Additionally, patients who receive chemotherapy for GCTs can develop complications including irreversible neurotoxicity (10%), ototoxicity (5-12%), pulmonary toxicity, which may result in permanent restrictive lung disease (8%), metabolic syndrome (10-16%), and hypogonadism (4%). Additionally, patients are at an approximate 3-7-fold increase in cardiovascular mortality and a two-fold increase in secondary solid malignancies and leukaemia. Furthermore, both treatment modalities can harm fertility potential by approximately 20-30%.

However, in the past few years, a number of prospective single arm studies have been published evaluating the role of RPLND. RPLND is an appealing choice for patients with low-volume metastatic seminoma for several reasons: Firstly, seminoma exhibits a more indolent biological behaviour and a predictable lymphatic spread pattern compared to non-seminoma diseases, potentially allowing a greater chance of cure with surgery alone. Secondly, RPLND enables precise pathological staging which can avoid overtreatment in those with pathologically negative lymph nodes. It offers an opportunity to reduce the burden of chemotherapy by reserving this treatment only for the small proportion of men who will relapse following RPLND. Finally, RPLND offers an acceptably low risk of short or long-term complications when performed at experienced centres.

Therefore, our objective is to prospectively evaluate the short and long-term safety and efficacy of Primary Retroperitoneal Lymph Node Dissection (RPLND) for patients with testicular seminoma and limited retroperitoneal lymph node metastasis.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Western Ontario, Canada

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Retroperitoneal Lymph Node Dissection
Open bilateral nerve-sparing RPLND.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival
Time Frame: 2 years
2-year RFS (absence of radiological metastases on cross-sectional imaging and normal serum tumour markers).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 90 days
Complications post RPLND (Clavein-Dindo)
90 days
Length of Stay in hospital
Time Frame: 90 days
Length of stay in hospital post RPLND
90 days
Treatment-Free Survival
Time Frame: 24 months
Patients avoiding additional treatments for seminoma post RPLND (e.g. chemotherapy / radiotherapy)
24 months
Cancer-specific Survival
Time Frame: 24 months
Percentage of people who have not died from testicular cancer during follow-up
24 months
Overall Survival
Time Frame: 2 years
Patients alive during follow-up
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 17, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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