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

NCT06932458 | Recruiting Phase 2 DMC

• 1 other identifier: 126353
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Seminoma; Retroperitoneal lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  2-year RFS (absence of radiological metastases on cross-sectional imaging and normal serum tumour markers).

  2 years

Secondary Outcomes (5)

• Complications

  90 days

• Length of Stay in hospital

  90 days

• Treatment-Free Survival

  24 months

• Cancer-specific Survival

  24 months

• Overall Survival

  2 years

Study Arms (1)

CS IIA/IIB Seminoma

OTHER

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

Interventions

Retroperitoneal Lymph Node Dissection PROCEDURE

Open bilateral nerve-sparing RPLND.

CS IIA/IIB Seminoma

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any condition deemed by the treating surgeon to pose an unacceptable risk for retroperitoneal lymph node dissection
• Any non-seminoma component on the orchiectomy specimen.
• AFP \>20 at any time point, pre- or post-orchiectomy.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Related Publications (3)

• Fung C, Dinh P Jr, Ardeshir-Rouhani-Fard S, Schaffer K, Fossa SD, Travis LB. Toxicities Associated with Cisplatin-Based Chemotherapy and Radiotherapy in Long-Term Testicular Cancer Survivors. Adv Urol. 2018 Feb 18;2018:8671832. doi: 10.1155/2018/8671832. eCollection 2018.

  PMID: 29670654 BACKGROUND

• Fossa SD, Dahl AA, Thorsen L, Hellesnes R, Kiserud CE, Tandstad T, Brydoy M, Haugnes HS, Myklebust TA. Mortality and Second Cancer Incidence After Treatment for Testicular Cancer: Psychosocial Health and Lifestyle Are Modifiable Prognostic Factors. J Clin Oncol. 2022 Aug 10;40(23):2588-2599. doi: 10.1200/JCO.21.02105. Epub 2022 Apr 5.

  PMID: 35380874 BACKGROUND

• Hamilton RJ, Canil C, Shrem NS, Kuhathaas K, Jiang MD, Chung P, North S, Czaykowski P, Hotte S, Winquist E, Kollmannsberger C, Aprikian A, Soulieres D, Tyldesley S, So AI, Power N, Rendon RA, O'Malley M, Wood L. Canadian Urological Association consensus guideline: Management of testicular germ cell cancer. Can Urol Assoc J. 2022 Jun;16(6):155-173. doi: 10.5489/cuaj.7945. No abstract available.

  PMID: 35623007 BACKGROUND

MeSH Terms

Conditions

Testicular Neoplasms; Seminoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type

Central Study Contacts

Kaydee Connors

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CA (1)