Actively Recruiting

Phase 2
Age: 18Years +
MALE
ID06932458

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

Led by Western University, Canada · Updated on 2025-07-20

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Testicular cancer is a rare adult cancer but the most common solid tumor in young men, with about 90% being germ cell tumors classified as seminoma or non-seminoma. Around 20% of seminoma patients have clinical stage II disease with limited retroperitoneal lymph node metastases. This trial explores an alternative to standard radiotherapy or chemotherapy treatments, which carry risks of serious short- and long-term side effects, by evaluating the role of surgery called Primary Retroperitoneal Lymph Node Dissection (RPLND).

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult males older than 18 years with pure seminoma on orchiectomy specimen
  • Initial clinical stage I with retroperitoneal relapse or de novo clinical stage II at presentation
  • Axial imaging of lymphadenopathy within 8 weeks of planned surgery
  • No more than 2 enlarged retroperitoneal lymph nodes, each 3 cm or smaller
  • Suitable for bilateral nerve-sparing retroperitoneal lymph node dissection
  • Normal serum tumor markers (AFP, HCG, LDH) within 2 weeks before planned surgery
Not Eligible

You will not qualify if you...

  • Any condition considered too risky for retroperitoneal lymph node dissection by the surgeon
  • Presence of non-seminoma component on orchiectomy specimen
  • Serum alpha-fetoprotein (AFP) level above 20 at any time before or after orchiectomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay of up to 90 days

Participants undergo open bilateral nerve-sparing Retroperitoneal Lymph Node Dissection (RPLND) surgery and receive immediate post-operative care.

Approximately 1 hospital stay

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored after surgery for safety, recovery, and recurrence of cancer.

Follow-up visits over 24 months

Trial Site Locations

Total: 1 location

1

London Health Sciences Centre

London, Ontario, Canada

Actively Recruiting

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Research Team

K

Kaydee Connors

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Toxicities Associated with Cisplatin-Based Chemotherapy and Radiotherapy in Long-Term Testicular Cancer Survivors.

Chunkit Fung, Paul Dinh, Shirin Ardeshir-Rouhani-Fard...

https://pubmed.ncbi.nlm.nih.gov/29670654

Mortality and Second Cancer Incidence After Treatment for Testicular Cancer: Psychosocial Health and Lifestyle Are Modifiable Prognostic Factors.

Sophie D Fosså, Alv A Dahl, Lene Thorsen...

https://pubmed.ncbi.nlm.nih.gov/35380874