Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:16 - Any
Updated:3/24/2019
Start Date:August 28, 2015
End Date:August 28, 2020
Contact:Ileana Aldana
Email:Ileana.aldana@med.usc.edu
Phone:323-865-0702

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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)

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.

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.

Inclusion 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.

Exclusion Criteria:

- 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
We found this trial at
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sites
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Principal Investigator: Timothy C. Brand, MD
Phone: 253-968-2300
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Mehrdad Alemozaffar, MD
Phone: 404-778-4823
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Phil Pierorazio, MD
Phone: 410-502-2299
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Clint Cary, MD
Phone: 317-274-3148
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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12605 East 16th Avenue
Aurora, Colorado 80045
Principal Investigator: Nicholas Cost, MD
Phone: 303-724-8635
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Aurora, CO
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Scott Eggener, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Dallas, Texas 75390
Principal Investigator: Aditya Bagrodia, MD
Phone: 214-645-8765
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Brian R Hu, MD
Phone: 909-558-7117
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Siamak Daneshmand, MD
Phone: 323-865-0702
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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New Brunswick, New Jersey 08903
Principal Investigator: Thomas Jang, MD
Phone: 732-235-7771
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Oklahoma City, Oklahoma 73104
Principal Investigator: Kelly Stratton, MD
Phone: 405-271-8777
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Rochester, Minnesota 55905
Principal Investigator: Steve Boorjian, MD
Phone: 507-266-8788
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San Francisco, California 94143
Principal Investigator: Maxwell V Meng, MD
Phone: 415-514-0554
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900 Quarry Road Extension
Stanford, California 94305
(650) 723-5111
Principal Investigator: Eila Skinner, MD
Phone: 650-498-8496
Stanford University Hospitals and Clinics A LEADER IN THE BIOMEDICAL REVOLUTION , Stanford Medicine has...
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