Clinical trial · Interventional
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
Surgery in Early Metastatic Seminoma (SEMS): Phase II Trial of Retroperitoneal Lymph Node Dissection as First-Line Treatment for Testicular Seminoma With Isolated Retroperitoneal Disease (1-3cm)
NCT02537548CI-TRIAL-00114034active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphadenopathy | — | UNRESOLVED | — |
| Stage II Testicular Seminoma | Testicular Seminoma | CURATED_BROADER | 0.78 |
| Stage I Testicular Seminoma | Testicular Seminoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Retroperitoneal Lymph Node Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (RPLND)
- description
- Patients undergo RPLND.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Procedure: Retroperitoneal Lymph Node Dissection
Primary outcomes (1)
- measure
- RFS
- timeFrame
- From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND
- description
- Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. The recurrence location (pelvic, retroperitoneal, distant) will be calculated as a percentage of total recurrences to describe the clinical pattern of disease after relapse.
Secondary outcomes (3)
- measure
- Long-term RPLND complication rates
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Pure seminoma after orchiectomy presenting with isolated retropreritoneal lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse. Relapse should be within 3 years * Lymphadenopathy in the retroperitoneum: at least one lymph node 1-3 cm in greatest dimension, no lymph node \> 3 cm in greatest dimension, no more than 2 lymph nodes 1-3 cm in greatest dimension * Axial imaging of lymphadenopathy within 6 weeks of the date of RPLND * Retroperitoneal lymphadenopathy must be within the RPLND template * If there is borderline lymphadenopathy, defined as the largest retroperitoneal lymph node measuring 0.90 - 0.99 cm in the greatest dimension, an abdominal computed tomography (CT) scan should be repeated (recommend interval of 6 - 8 weeks); the same lymph node must demonstrate growth to \>= 1.0 cm in the greatest dimension * Biopsy is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with pure seminoma * Chest imaging (x-ray, CT or magnetic resonance imaging \[MRI\]) negative for metastasis no more than 6 weeks prior to the date of RPLND * Primary tumor excised by radical inguinal orchiectomy and pathology consistent with pure seminoma * Serum alpha fetoprotein (AFP) not more than 1.5 times upper limit of normal, beta-human chorionic gonadotropin (HCG), lactate dehydrogenase (LDH) (per the local laboratory assay) within 14 days of RPLND * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Ability to understand and the willingness to sign a written informed consent * Serum coagulation studies (INR/PTT) and platelet counts suitable for surgery per surgeon discretion. Exclusion Criteria: * Second primary malignancy * History of receiving chemotherapy or radiotherapy * Patients receiving any other investigational agent (s) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (2)
- DERIVEDHu B, Alsyouf M, Farkouh A, Cary C, Masterson T, Einhorn L, Adra N, Boorjian SA, Kollmannsberger C, Schuckman A, So A, Black PC, Bagrodia A, Skinner E, Alemozaffar M, Brand T, Eggener S, Pierorazio P, Stratton K, Nappi L, Nichols C, Daneshmand S. Accuracy of 18F-Fluorodeoxyglucose Positron Emission Tomography in Early Metastatic Testicular Seminoma: Analysis From the SEMS Trial. J Urol. 2025 Sep;214(3):272-279. doi: 10.1097/JU.0000000000004561. Epub 2025 Apr 9. PMID 40203124
- DERIVEDDaneshmand S, Cary C, Masterson T, Einhorn L, Adra N, Boorjian SA, Kollmannsberger C, Schuckman A, So A, Black P, Bagrodia A, Skinner E, Alemozaffar M, Brand T, Eggener S, Pierorazio P, Stratton K, Nappi L, Nichols C, Luo C, Li M, Hu B. Surgery in Early Metastatic Seminoma: A Phase II Trial of Retroperitoneal Lymph Node Dissection for Testicular Seminoma With Limited Retroperitoneal Lymphadenopathy. J Clin Oncol. 2023 Jun 1;41(16):3009-3018. doi: 10.1200/JCO.22.00624. Epub 2023 Mar 13. PMID 36913642