Retroperitoneal Lymph Node Dissection in Treating Patients with Testicular Seminoma with Lymphadenopathy or Stage I-IIB Testicular Seminoma
This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with testicular seminoma with enlarged lymph node or stage I-IIB 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.
- Pure seminoma after orchiectomy presenting with isolated retroperitoneal lymphadenopathy OR stage I to IIB 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
- Normal beta-human chorionic gonadotropin (HCG) (per the local laboratory assay) within 14 days of RPLND
- Serum alpha-fetoprotein (AFP) not greater than 1.5 times the upper limit of the local laboratory assay within 14 days of RPLND
- Serum lactate dehydrogenase (LDH) not greater than 1.5 times the upper limit of 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 (international normalized ratio [INR]/partial thromboplastin time [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
Locations & Contacts
Contact: Brian R. Hu
Contact: Ileana Aldana
Contact: Siamak Daneshmand
Contact: Eila Curlee Skinner
Contact: Maxwell V. Meng
Contact: Nicholas Glenn Cost
Contact: Mehrdad Alemozaffar
Contact: Scott E. Eggener
Contact: K. Clint Cary
Contact: Phillip Martin Pierorazio
Contact: Stephen A. Boorjian
Contact: Thomas Lee Jang
Contact: Kelly L. Stratton
Contact: Aditya Bagrodia
Contact: Celestina Wildman
Contact: Christian Kurt Kollmannsberger
Trial Objectives and Outline
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 (=< 3 cm) 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.
Trial Phase & Type
USC / Norris Comprehensive Cancer Center
Secondary IDs NCI-2015-01177, HS-15-00246
Clinicaltrials.gov ID NCT02537548