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Eligibility
for males ages 16 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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)

Details

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.

Keywords

Lymphadenopathy Stage I Testicular Seminoma Stage II Testicular Seminoma

Eligibility

You can join if…

Open to males ages 16 years and up

  • 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.

You CAN'T join if...

  • 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

  • USC / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90033, United States
  • Loma Linda University Medical Center accepting new patients
    Loma Linda, California, 92350, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Southern California
ID
NCT02537548
Lead Scientist
Maxwell Meng
Study Type
Interventional
Last Updated
June 1, 2017
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