Clinical trial · Interventional
A Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
A Phase II Single-arm Clinical Trial of Primary Retroperitoneal Lymph Node Dissection in Patients With Testicular Seminoma With Limited Retroperitoneal Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Retroperitoneal Lymph Node Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CS IIA/IIB Seminoma
- description
- Patients with relapsed CS I or de novo CS IIA/B with \<3cm lymph node in the retroperitoneal lymph node.
- interventionNames
- Procedure: Retroperitoneal Lymph Node Dissection
Primary outcomes (1)
- measure
- Recurrence Free Survival
- timeFrame
- 2 years
- description
- 2-year RFS (absence of radiological metastases on cross-sectional imaging and normal serum tumour markers).
Secondary outcomes (5)
- measure
- Complications
- timeFrame
- 90 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDFung 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
- BACKGROUNDFossa 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
- BACKGROUNDHamilton 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