Clinical protocol: RCT - Lymphadenectomy in urothelial carcinoma in the renal pelvis and ureter

Clinical protocol
LYMPHADENECTOMY IN UROTHELIAL CARCINOMA IN THE RENAL PELVIS AND URETER- A RANDOMIZED INTERNATIONAL CLINICAL TRIAL ON LYMPHADENECTOMY IN UROTHELIAL CARCINOMA IN THE RENAL PELVIS AND URETER
August 2016

 Background:
Two out of three tumors in the upper urinary tract are located in the renal pelvis [1]. Muscle-invasive urothelial carcinoma is probably more common among tumors in the upper urinary tract compared to tumors in the urinary bladder. Thus, muscle-invasive tumors represent approximately 45 % of renal pelvic tumors [2,3] compared to 25 % of tumors within the urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive disease. Information regarding indications, extent and possible curative potential is currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with survival data for pa-tients with lymph node metastasis that report long term survival after surgery as monotherapy [4] with similar survival proportions as in bladder cancer with lymph node metastases after radical cystectomy. A retrospective study from Tokyo [5] was expanded to the only available prospective study, where 68 patients with UUTUC were submitted to template-based lymphad-enectomy [6]. Another retrospective study by the same Japanese group showed that 5-year cancer-specific and recurrence-free survival was significantly higher in the complete lymphadenectomy group than in the incomplete lymphadenectomy or without lymphadenectomy groups [7]. Tanaka N et al. reported recurrence rate after nephroureterectomy without lymphadenec-tomy at 1 and 3 years were 18.9 and 29.8 %, respectively [8].....

 Design: Prospectively randomized to template based lymphadenectomy or not, in patients with clinically muscle-invasive UUTUC in the renal pelvis or upper 2/3 of the ureter. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 183 patients in each group. Group A will be scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy except for clinically enlarged. Group B will be scheduled to receive mapped lymphadenectomy in conjugation with nephroureterectomy.