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Active, not recruitingNCT02537548Updated Jun 9, 2026

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

An interventional study of Laboratory Biomarker Analysis and Retroperitoneal Lymph Node Dissection in Lymphadenopathy, Stage I Testicular Seminoma and Stage II Testicular Seminoma, sponsored by University of Southern California. Active, not recruiting at 14 sites in United States. Open to male participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by University of Southern California · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
16 Years and older
Sex
Male
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES:

I. Assess the recurrence free survival (RFS) at 2 years after RPLND when RPLND is used as a first line treatment for patients with testicular seminoma and low volume (=\< 2cm) retroperitoneal disease.

SECONDARY OBJECTIVES:

I. Estimate the percent of patients, after treatment with RPLND, who can avoid external beam radiotherapy (XRT) or systemic chemotherapy (CTX) for seminoma.

II. Assess the complications associated with primary RPLND for seminoma.

OUTLINE:

Patients undergo RPLND.

After completion of study treatment, patients are followed up at 1 month, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

02

Conditions studied

  • Lymphadenopathy
  • Stage I Testicular Seminoma
  • Stage II Testicular Seminoma
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Treatment (RPLND)

    Patients undergo RPLND.

    Other: Laboratory Biomarker Analysis · Procedure: Retroperitoneal Lymph Node Dissection

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • ProcedureRetroperitoneal Lymph Node Dissection

    Undergo RPLND

    Also known as: RPLND

05

What researchers measure

Primary outcomes

  1. RFS

    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.

    Time frame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND

Secondary outcomes

  1. Long-term RPLND complication rates

    The rate of short and long term complications will be calculated.

    Time frame: Up to 5 years

  2. RFS

    Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method.

    Time frame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 5 years after RPLND

  3. Short-term RPLND complication rates

    The rate of short and long term complications will be calculated.

    Time frame: Up to 12 months

06

Study locations

14 sites
  • Loma Linda University Medical Center
    Loma Linda, California 92350, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Stanford University Hospitals & Clinics
    Stanford, California 94305, United States
  • University of Colorado Hospital - Aurora
    Aurora, Colorado 80045, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21205, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08903-2681, United States
  • Stephenson Cancer Center, University of Oklahoma
    Oklahoma City, Oklahoma 73104, United States
  • UTSouthwestern Medical Center
    Dallas, Texas 75390-9110, United States
  • Madigan Army Medical Center
    Tacoma, Washington 98431, United States
07

References and documents

Publications

  • Hu 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. PubMed 40203124 ↗
  • Daneshmand 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. PubMed 36913642 ↗
08

Registry details

Key details

Study ID
NCT02537548
Lead sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 1, 2015
Start date
Aug 28, 2015
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 9, 2026

Study contacts

Siamak Daneshmand
principal investigator · University of Southern California

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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