Spots Global Cancer Trial Database for Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
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Trial Identification
Brief Title: Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
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)
Study ID: NCT02537548
Study Description
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.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Loma Linda University Medical Center, Loma Linda, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California, San Francisco, San Francisco, California, United States
Stanford University Hospitals & Clinics, Stanford, California, United States
University of Colorado Hospital - Aurora, Aurora, Colorado, United States
Emory University, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Mayo Clinic, Rochester, Minnesota, 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
UTSouthwestern Medical Center, Dallas, Texas, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Contact Details
Name: Siamak Daneshmand
Affiliation: University of Southern California
Role: PRINCIPAL_INVESTIGATOR
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