Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02537548|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphadenopathy Stage I Testicular Seminoma Stage II Testicular Seminoma||Other: Laboratory Biomarker Analysis Procedure: Retroperitoneal Lymph Node Dissection||Not Applicable|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||August 28, 2015|
|Estimated Primary Completion Date :||August 28, 2025|
|Estimated Study Completion Date :||August 28, 2026|
Experimental: Treatment (RPLND)
Patients undergo RPLND.
Other: Laboratory Biomarker Analysis
Procedure: Retroperitoneal Lymph Node Dissection
Other Name: RPLND
- RFS [ Time Frame: 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.
- Long-term RPLND complication rates [ Time Frame: Up to 5 years ]The rate of short and long term complications will be calculated.
- RFS [ Time Frame: 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.
- Short-term RPLND complication rates [ Time Frame: Up to 12 months ]The rate of short and long term complications will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537548
|United States, California|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92350|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Stanford University Hospitals & Clinics|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado Hospital - Aurora|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21205|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903-2681|
|United States, Oklahoma|
|Stephenson Cancer Center, University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|UTSouthwestern Medical Center|
|Dallas, Texas, United States, 75390-9110|
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Siamak Daneshmand||University of Southern California|