Phase II trial of retroperitoneal lymph node dissection as first-line treatment for testicular seminoma with isolated retroperitoneal disease (1-2cm)
Investigation of Surgery for Treating Testicular Seminoma
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: seminoma
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Age: 16 years - 100 years
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Gender: All
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
The purpose of this study is to evaluate the safety and effectiveness of Retroperitoneal Lymph Node Dissection (RPLND) as a treatment for seminoma that has spread to the lymph nodes in the retroperitoneum. The retroperitoneum is an area in the body located behind the intestines and is often the first place where seminoma spreads. Seminoma is a type of testicular cancer, and RPLND is a surgical procedure to remove these lymph nodes.
In this study, participants will undergo a surgical procedure called RPLND to treat testicular seminoma. This surgery involves the removal of lymph nodes in the retroperitoneum and may result in fewer long-term side effects, such as the risk of developing a second cancer, heart disease, metabolic issues, or lung disease.
- Who can participate: Men with stage IIA pure seminoma or stage I pure seminoma with isolated retroperitoneal relapse are eligible if they have lymphadenopathy in the retroperitoneum and negative chest imaging for metastasis within six weeks before RPLND. The primary tumor must have been removed through radical inguinal orchiectomy with negative surgical margins.
- Study details: Participants will undergo a surgical procedure called RPLND to remove lymph nodes in the retroperitoneum. This surgery aims to treat testicular seminoma and may result in fewer long-term side effects.
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