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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (RPLND) | Experimental | Patients undergo RPLND. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term RPLND complication rates | The rate of short and long term complications will be calculated. | Up to 5 years |
| RFS | Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Siamak Daneshmand | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92350 | United States | ||
| USC / Norris Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40203124 | Derived | Hu B, Alsyouf M, Farkouh A, Cary C, Masterson T, Einhorn L, Adra N, Boorjian SA, Kollmannsberger C, Schuckman A, So A, Black PC, Bagrodia A, Skinner E, Alemozaffar M, Brand T, Eggener S, Pierorazio P, Stratton K, Nappi L, Nichols C, Daneshmand S. Accuracy of 18F-Fluorodeoxyglucose Positron Emission Tomography in Early Metastatic Testicular Seminoma: Analysis From the SEMS Trial. J Urol. 2025 Sep;214(3):272-279. doi: 10.1097/JU.0000000000004561. Epub 2025 Apr 9. | |
| 36913642 |
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| Retroperitoneal Lymph Node Dissection |
| Procedure |
Undergo RPLND |
|
|
| From RPLND to the time of recurrence or death, whichever comes first., assessed at 5 years after RPLND |
| Short-term RPLND complication rates | The rate of short and long term complications will be calculated. | Up to 12 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Hospitals & Clinics | Stanford | California | 94305 | United States |
| University of Colorado Hospital - Aurora | Aurora | Colorado | 80045 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903-2681 | United States |
| Stephenson Cancer Center, University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| UTSouthwestern Medical Center | Dallas | Texas | 75390-9110 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| Daneshmand S, Cary C, Masterson T, Einhorn L, Adra N, Boorjian SA, Kollmannsberger C, Schuckman A, So A, Black P, Bagrodia A, Skinner E, Alemozaffar M, Brand T, Eggener S, Pierorazio P, Stratton K, Nappi L, Nichols C, Luo C, Li M, Hu B. Surgery in Early Metastatic Seminoma: A Phase II Trial of Retroperitoneal Lymph Node Dissection for Testicular Seminoma With Limited Retroperitoneal Lymphadenopathy. J Clin Oncol. 2023 Jun 1;41(16):3009-3018. doi: 10.1200/JCO.22.00624. Epub 2023 Mar 13. |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D018239 | Seminoma |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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