Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Not Recruiting

Trial ID: NCT02537548


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.

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)

Stanford Investigator(s)

Eila C. Skinner
Eila C. Skinner

Thomas A. Stamey Research Professor of Urology

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Harcharan Gill
Harcharan Gill

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

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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