NCT02537548

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2015Aug 2027

Study Start

First participant enrolled

August 28, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2027

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

11 years

First QC Date

August 29, 2015

Last Update Submit

August 7, 2025

Conditions

LymphadenopathyStage I Testicular SeminomaStage II Testicular Seminoma

Outcome Measures

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.

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

Secondary Outcomes (3)

  • Long-term RPLND complication rates

    Up to 5 years

  • RFS

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

  • Short-term RPLND complication rates

    Up to 12 months

Study Arms (1)

Treatment (RPLND)

EXPERIMENTAL

Patients undergo RPLND.

Other: Laboratory Biomarker AnalysisProcedure: Retroperitoneal Lymph Node Dissection

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (RPLND)
Retroperitoneal Lymph Node DissectionPROCEDURE

Undergo RPLND

Also known as: RPLND
Treatment (RPLND)

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Hospitals & Clinics

Stanford, California, 94305, United States

Location

University of Colorado Hospital - Aurora

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903-2681, United States

Location

Stephenson Cancer Center, University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

UTSouthwestern Medical Center

Dallas, Texas, 75390-9110, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (1)

  • 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.

    PMID: 36913642DERIVED

MeSH Terms

Conditions

LymphadenopathySeminoma

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesGerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Siamak Daneshmand

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2015

First Posted

September 1, 2015

Study Start

August 28, 2015

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2027

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

US(14)