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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphadenopathy; Stage I Testicular Seminoma; Stage II Testicular Seminoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Retroperitoneal Lymph Node Dissection

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (RPLND); Patients undergo RPLND.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Retroperitoneal Lymph Node Dissection; Undergo RPLND; Other Names: RPLND

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term RPLND complication rates	The rate of short and long term complications will be calculated.	Up to 5 years
RFS	Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method.	From RPLND to the time of recurrence or death, whichever comes first., assessed at 5 years after RPLND
Short-term RPLND complication rates	The rate of short and long term complications will be calculated.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Siamak Daneshmand, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2015
• Primary Completion (Estimated): August 28, 2025
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: August 29, 2015
• First Submitted That Met QC Criteria: August 29, 2015
• First Posted (Estimated): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms, Germ Cell and Embryonal; Germinoma; Lymphadenopathy; Seminoma
• Other Study ID Numbers: 4T-14-1 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2015-01177 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HS-15-00246

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No