Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Not Applicable

Active, not recruiting

• Conditions: Lymphadenopathy; Stage I Testicular Seminoma; Stage II Testicular Seminoma
• Interventions: Other: Laboratory Biomarker Analysis; Procedure: Retroperitoneal Lymph Node Dissection

• Registration Number: NCT02537548
• Lead Sponsor: University of Southern California

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2015-08-28
• Study First Submitted: 2015-08-29
• Study First Submitted QC: 2015-08-29
• Study First Posted: 2015-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-08-28
• Study Completion: 2026-08-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 55

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (RPLND)	Retroperitoneal Lymph Node Dissection	Patients undergo RPLND.
Treatment (RPLND)	Laboratory Biomarker Analysis	Patients undergo RPLND.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

University of Colorado Hospital - Aurora; 🇺🇸 Aurora, Colorado, United States

Stanford University Hospitals & Clinics; 🇺🇸 Stanford, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

UTSouthwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Stephenson Cancer Center, University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States