Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

Study Overview
=================
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.

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)

Conditions
-----------------
Lymphadenopathy, Stage I Testicular Seminoma, Stage II Testicular Seminoma

Intervention / Treatment
-----------------
* Other: Laboratory Biomarker Analysis
* Procedure: Retroperitoneal Lymph Node Dissection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (RPLND)<br>Patients undergo RPLND. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Retroperitoneal Lymph Node Dissection<br>* Undergo RPLND<br>* Other names: RPLND;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFS | Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. The recurrence location (pelvic, retroperitoneal, distant) will be calculated as a percentage of total recurrences to describe the clinical pattern of disease after relapse. | From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term RPLND complication rates | The rate of short and long term complications will be calculated. | Up to 5 years | 
| RFS | Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method. | From RPLND to the time of recurrence or death, whichever comes first., assessed at 5 years after RPLND | 
| Short-term RPLND complication rates | The rate of short and long term complications will be calculated. | Up to 12 months |