Retroperitoneal Lymph Node Dissection in Treating Patients with Testicular Seminoma with Lymphadenopathy or Stage I Testicular Seminoma

Status: Active

Description

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 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.

Eligibility Criteria

Inclusion Criteria

  • Pure seminoma after orchiectomy presenting with isolated retroperitoneal 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 with negative surgical margins
  • 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

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

Locations & Contacts

California

Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Brian R. Hu
Phone: 909-558-7117
Email: Brianrhu@med.usc.edu
Los Angeles
Los Angeles County-USC Medical Center
Status: Active
Contact: Ileana Aldana
Phone: 323-865-0702
Email: Ileana.aldana@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Siamak Daneshmand
Phone: 323-865-3700
Email: daneshma@med.usc.edu
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Eila Curlee Skinner
Phone: 650-723-0948
Email: Skinnere@stanford.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Maxwell V. Meng
Phone: 415-514-0554
Email: Max.Meng@ucsf.edu

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Mehrdad Alemozaffar
Phone: 404-778-4898
Email: malemoz@emory.edu

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Scott E. Eggener
Phone: 773-702-1860
Email: seggener@surgery.bsd.uchicago.edu

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: K. Clint Cary
Phone: 317-948-9272
Email: kcary@iupui.edu

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Phillip Martin Pierorazio
Phone: 410-502-2299
Email: philpierorazio@jhmi.edu

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Stephen A. Boorjian
Phone: 507-266-8788
Email: Boorjian.Stephen@mayo.edu

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Thomas Lee Jang
Phone: 732-235-8861
Email: jangtl@cinj.rutgers.edu

Oklahoma

Oklahoma City
Stephenson Cancer Center
Status: Active
Contact: Kelly L. Stratton
Phone: 405-271-8777
Email: Kelly-Stratton@ouhsc.edu

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Aditya Bagrodia
Phone: 214-648-9626
Email: Aditya.bagrodia@utsouthwestern.edu

British Columbia

Vancouver
BCCA-Vancouver Cancer Centre
Status: Active
Contact: Christian Kurt Kollmannsberger
Phone: 604-877-6000
Email: John.Mah3@bccancer.bc.ca

Trial Objectives and Outline

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 (=< 3 cm) 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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
USC / Norris Comprehensive Cancer Center

Principal Investigator
Siamak Daneshmand

Trial IDs

Primary ID 4T-14-1
Secondary IDs NCI-2015-01177, HS-15-00246
Clinicaltrials.gov ID NCT02537548