Clinical trial NCT02537548: Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphadenopathy
Stage I Testicular Seminoma
Stage II Testicular Seminoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-09-01
Enrollment: 55
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: RFS
timeFrame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND
Secondary outcomes:
measure: Long-term RPLND complication rates
timeFrame: Up to 5 years
measure: RFS
timeFrame: From RPLND to the time of recurrence or death, whichever comes first., assessed at 5 years after RPLND
measure: Short-term RPLND complication rates
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Hospitals & Clinics
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Aurora
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center, University of Oklahoma
state: Oklahoma
city: Dallas
country: United States
facility: UTSouthwestern Medical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Southern California
name: Siamak Daneshmand
role: PRINCIPAL_INVESTIGATOR
References: