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NCT02537548Active, not recruiting

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)

Source: ClinicalTrials.gov · Last updated 9 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
55 (actual)
First submitted
29 Aug 2015
Start date
28 Aug 2015
Primary completion date
31 Dec 2026
Lead sponsor
University of Southern California
NCT number
NCT02537548

What you commit to

  • Study type: Interventional
  • Participants enrolled: 55
  • From 28 Aug 2015 to the primary completion date, 31 Dec 2026
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of receiving chemotherapy or radiotherapy
  • Patients receiving any other investigational agent (s)

Other illness

  • Second primary malignancy
  • 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

Who the study is looking for

  • 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.

Age in the registry: 16 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University
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AtlantaUnited StatesUnknown status
University of Colorado Hospital - Aurora
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AuroraUnited StatesUnknown status
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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BaltimoreUnited StatesUnknown status
University of Chicago Medical Center
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ChicagoUnited StatesUnknown status
UTSouthwestern Medical Center
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DallasUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Loma Linda University Medical Center
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Loma LindaUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
Stephenson Cancer Center, University of Oklahoma
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Oklahoma CityUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Stanford University Hospitals & Clinics
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StanfordUnited StatesUnknown status
Madigan Army Medical Center
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TacomaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.