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.
Phase II Trial of Retroperitoneal Lymph Node Dissection as First-Line Treatment for Testicular Seminoma With Isolated Retroperitoneal Disease (1-2cm)
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.
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.
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.
LymphadenopathyStage I Testicular SeminomaStage II Testicular Seminoma
You can join if…
Open to males ages 16 years and up
Stage IIA pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse
Lymphadenopathy in the retroperitoneum: at least one lymph node 1-2 cm in greatest dimension, no lymph node> 2 cm in greatest dimension, no more than 2 lymph nodes 1-2 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 with negative surgical margins
Normal serum alpha fetoprotein (AFP), 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
Platelet count> 150,000
International normalized ratio (INR) < 1.3
Normal partial thromboplastin time (PTT) per the local laboratory assay
You CAN'T join if...
Second primary malignancy
History of receiving chemotherapy or radiotherapy
Patients receiving any other investigational agent (s)
Any history of serum AFP elevation (including prior to orchiectomy)
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
University of California, San Franciscoaccepting new patients San Francisco, California, 94143, USA
Loma Linda University Medical Centeraccepting new patients Loma Linda, California, 92350, USA
USC / Norris Comprehensive Cancer Centeraccepting new patients Los Angeles, California, 90033, USA