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LymphadenopathyNCT02537548

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

A study testing Laboratory Biomarker Analysis and Retroperitoneal Lymph Node Dissection in people with Lymphadenopathy and Stage I Testicular Seminoma, run by University of Southern California at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, men only
What is being tested?
Laboratory Biomarker Analysis and Retroperitoneal Lymph Node Dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
14 sitesUnited States
Study dates
28 Aug 2015to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Hospital - Aurora

    Aurora, Colorado, 80045

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21205

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • UTSouthwestern Medical Center

    Dallas, Texas, 75390-9110

  • Indiana University

    Indianapolis, Indiana, 46202

  • Loma Linda University Medical Center

    Loma Linda, California, 92350

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903-2681

  • Stephenson Cancer Center, University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, San Francisco

    San Francisco, California, 94143

  • Stanford University Hospitals & Clinics

    Stanford, California, 94305

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

Other trials in United States

About this study

Official title: 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)

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:

  1. 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:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Retroperitoneal Lymph Node Dissection
Medical subject headings
Lymphadenopathy, Seminoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Retroperitoneal Lymph Node DissectionProcedure or surgery

    Also called RPLND

    Undergo RPLND

Study groups in NCT02537548
Study groupRoleWhat they receive
Treatment (RPLND)ExperimentalPatients undergo RPLND.
Receives: Other: Laboratory Biomarker Analysis; Procedure: Retroperitoneal Lymph Node Dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Long-term RPLND complication rates

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

    Measured: Up to 5 years

  2. RFS

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

    Measured: 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2015 (estimated)
  2. Study start28 Aug 2015
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02537548
Sponsor's protocol ID
4T-14-1
Other IDs
NCI-2015-01177, HS-15-00246, 4T-14-1, P30CA014089
Status last verified
Jun 2026
First submitted
29 Aug 2015
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Laboratory Biomarker Analysis and Retroperitoneal Lymph Node Dissection in people with Lymphadenopathy and Stage I Testicular Seminoma, run by University of Southern California at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS (time frame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537548, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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