Clinical Trials /

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

NCT02537548

Description:

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.

Related Conditions:
  • Testicular Seminoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: 4T-14-1
  • SECONDARY ID: NCI-2015-01177
  • SECONDARY ID: HS-15-00246
  • SECONDARY ID: 4T-14-1
  • SECONDARY ID: P30CA014089
  • NCT ID: NCT02537548

Conditions

  • Lymphadenopathy
  • Stage I Testicular Seminoma
  • Stage II Testicular Seminoma

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (RPLND)ExperimentalPatients undergo RPLND.

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:16 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:RFS
    Time Frame:From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND
    Safety Issue:
    Description: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.

    Secondary Outcome Measures

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

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Southern California

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