Phase II trial of retroperitoneal lymph node dissection as first-line treatment for testicular seminoma with isolated retroperitoneal disease (1-2cm)

Age
1 month - 12 months
Gender
All
Phase
Phase 2
Participants needed
10
Phase II trial of retroperitoneal lymph node dissection as first-line treatment for testicular seminoma with isolated retroperitoneal disease (1-2cm)
Department
Primary Investigator
AS

Abdulkader Sinno

AR

A. John Spittler, RN

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Brief description of study

The purpose of this study is to evaluate the safety and effectiveness of Retroperitoneal Lymph Node Dissection (RPLND) as a treatment option for seminoma that has gone to the lymph nodes in the retroperitoneum.
 

Detailed description of study

 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.
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: acne,cancer,diabetes
  • Age: 1 month - 12 months
  • Gender: All

You may be eligible for this study if you meet the following criteria:
  • Conditions: seminoma
  • Age: Between 16 Years - 100 Years
  • Gender: Male or Female
 
Inclusion Criteria
Stage IIA pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse
Lymphadenopathy in the retroperitoneum
Chest imaging 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
Exclusion Criteria
Second primary malignancy
History of receiving chemotherapy or radiotherapy
Patients receiving any other investigational agents
Any history of serum AFP elevation
Uncontrolled intercurrent illness


Additional Information:
 

Participants will not be paid for their participation.
 
 
 

Updated on 28 Jan 2025. Study ID: NCT20921

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