Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : August 9, 2022
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Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
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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.
| 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 55 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (RPLND)
Patients undergo RPLND.
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Other: Laboratory Biomarker Analysis
Correlative studies Procedure: Retroperitoneal Lymph Node Dissection Undergo RPLND
Other Name: RPLND |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
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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
Information from the National Library of Medicine
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
Locations
| 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 | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Minnesota | |
| Mayo Clinic | |
| 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 | |
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Siamak Daneshmand | University of Southern California |
| Responsible Party: | University of Southern California |
| ClinicalTrials.gov Identifier: | NCT02537548 |
| Other Study ID Numbers: |
4T-14-1 NCI-2015-01177 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) HS-15-00246 4T-14-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 1, 2015 Key Record Dates |
| Last Update Posted: | August 9, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Seminoma Lymphadenopathy Germinoma Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Lymphatic Diseases |