A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
Launched by WESTERN UNIVERSITY, CANADA · Apr 9, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a surgical approach called retroperitoneal lymph node dissection (RPLND) for men with testicular seminoma, a type of testicular cancer. Specifically, it focuses on patients who have a limited spread of cancer to the lymph nodes in the abdomen, which are enlarged but still small (no more than 3 cm). While there are effective treatments like chemotherapy and radiation that can cure about 90% of these cases, some patients and doctors are concerned about the long-term side effects of those treatments. This trial aims to see if surgery can be a safer option for these patients.
To be eligible for the trial, participants must be adult men (over 18) who have been diagnosed with pure seminoma after surgery to remove a testicle. They should have either had a relapse of cancer after initial treatment or have been diagnosed with advanced cancer at the start. Additionally, their imaging tests must show no more than two enlarged lymph nodes, and certain blood tests must be normal. This trial is not yet recruiting participants, but it could offer a new treatment path for men facing this challenge.
Gender
MALE
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.
About Western University, Canada
Western University, located in Canada, is a leading research institution committed to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its faculty and research teams to conduct high-quality studies that address pressing medical challenges. Western University is dedicated to fostering a culture of ethical research practices, ensuring participant safety, and generating impactful findings that contribute to evidence-based medicine and improve patient outcomes. Through its robust infrastructure and commitment to excellence, Western University plays a vital role in the field of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported