NCT02537548

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Retroperitoneal Lymph Node Dissection	Undergo RPLND

Timeline

• Start date: 2015-08-28
• Primary completion: 2026-08-28
• Completion: 2027-08-28
• First posted: 2015-09-01
• Last updated: 2025-08-11

Locations

14 sites across 1 country: United States