Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Running, not enrolling · Not applicable

Conditions studied: Lymphadenopathy, Stage I Testicular Seminoma, Stage II Testicular Seminoma

In brief

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.

Key facts

Study ID

NCT02537548

Run by

University of Southern California

People needed

55

Starts

2015-08-28

Expected to finish

2027-12-31

Last updated by the study team

2026-06-09

Who can join

Age: 16 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Hospitals & Clinics — Stanford, California, United States
• University of Colorado Hospital - Aurora — Aurora, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Stephenson Cancer Center, University of Oklahoma — Oklahoma City, Oklahoma, United States
• UTSouthwestern Medical Center — Dallas, Texas, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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