Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
Trial ID or NCT#
Status
NOT 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
- - 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.
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
(650) 498-7061
View on ClinicalTrials.gov