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Not Recruiting
Trial ID: NCT02537548
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)
Thomas A. Stamey Research Professor of Urology
Professor of Medicine (Oncology) and, by courtesy, of Urology
Kathryn Simmons Stamey Professor, Emeritus
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
- 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
other: Laboratory Biomarker Analysis
procedure: Retroperitoneal Lymph Node Dissection
Not Recruiting
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