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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (\>18 years) with pure seminoma on radical orchiectomy specimen.

• Initial CS I presentation with subsequent retroperitoneal relapse on surveillance, or de novo CS II at presentation.

• Axial imaging of lymphadenopathy within 8 weeks of the date of RPLND

‣ No more than 2 enlarged retroperitoneal lymph nodes, each no more than 3cm in the primary landing zones.

⁃ Suitable for proposed bilateral RPLND template

• 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

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Kaydee Connors
Kaydee.Connors@lhsc.on.ca
519-685-8500
Time Frame
Start Date: 2025-07-17
Estimated Completion Date: 2030-06-01
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Western University, Canada

This content was sourced from clinicaltrials.gov