Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Lymphadenopathy Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02537548
• Other study ID #: 4T-14-1
• Secondary ID: NCI-2015-01177HS
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2015
• Est. completion date: August 28, 2026

Study information

• Verified date: March 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: August 28, 2026
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Retroperitoneal Lymph Node Dissection
Undergo RPLND

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Hospital - Aurora	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Chicago Medical Center	Chicago	Illinois
United States	UTSouthwestern Medical Center	Dallas	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Loma Linda University Medical Center	Loma Linda	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Stephenson Cancer Center, University of Oklahoma	Oklahoma City	Oklahoma
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, San Francisco	San Francisco	California
United States	Stanford University Hospitals & Clinics	Stanford	California
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Long-term RPLND complication rates	The rate of short and long term complications will be calculated.	Up to 5 years
Secondary	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
Secondary	Short-term RPLND complication rates	The rate of short and long term complications will be calculated.	Up to 12 months