Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Trial ID or NCT#

NCT02537548

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Eligibility Criteria

Ages Eligible for Study: Older than 16 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Eila C. Skinner
Eila C. Skinner
Urologic oncologist, Urologist, Urologic surgeon
Thomas A. Stamey Research Professor of Urology
Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology
Harcharan Gill
Harcharan Gill
Urologic oncologist, Urologist, Genitourinary specialist, Urologic surgeon
Kathryn Simmons Stamey Professor, Emeritus

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov