Retroperitoneal Lymph Node Dissection as Primary Treatment for Metastatic Seminoma
Table 3
Prospective clinical trials of RPLND in seminoma.
SEMS (Surgery in Early Metastatic Seminoma)
PRIMETEST (Trial to Evaluate Progression Free Survival with Primary Retroperitoneal Lymph-Node Dissection (pRPLND) Only in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B)
Phase
II
II
Inclusion criteria
Testicular seminoma Retroperitoneal lymph node 1–3 cm in size No more than two enlarged lymph nodes
Testicular seminoma Inguinal, paraaortic, or retroperitoneal lymph nodes classified as local or regional unilateral metastasis Maximum dimensions of lymph node metastasis 5 cm Allow patients who have received single dose carboplatin for stage I seminoma
Exclusion criteria
Second primary malignancy History of radiation/chemotherapy
Prior scrotal or retroperitoneal surgery History of radiation/chemotherapy (other than carboplatin)
Serum tumor markers
Beta-HCG normal Allow LDH and AFP up to 1.5 times upper limit of normal
Exclude AFP elevation suspicious for NSGCT
Primary endpoint
2-year recurrence-free survival
3-year progression-free survival
Secondary endpoints
5-year recurrence-free survival Treatment-free survival (time free from radiotherapy or chemotherapy) Complication rate (long and short term)
Overall survival Quality of life Complication rate Long-term sequelae
Accrual goal
46
30
Start date
August 2015
June 2016
Target completion date
August 2020
June 2021
Number of institutions
9
1
Primary location
University of Southern California
Department of Urology, Heinrich-Heine University, Duesseldorf
