Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma (NCT02537548) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma
United States55 participantsStarted 2015-08-28
Plain-language 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.
Who can participate
Age range16 Years
SexMALE
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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)…
What they're measuring
1
RFS
Timeframe: From RPLND to the time of recurrence or death, whichever comes first., assessed at 2 years after RPLND