ymphadenectomy 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

Completed

Conditions: cancer of the renal pelvis and ureter
upper tract urothelial carcinoma
10038364
10046400
10038365

Registration Number: NL-OMON45429

Lead Sponsor: Zealand University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

-written informed consent
-age >17 years
-Eastern Cooperative Oncology Group (ECOG) performance status 0-2;All patients need at least one criterium of A and one of B.
A. Histological defined upper tract urothelial carcinoma (UTUC): histologically confirmed diagnosis of predominantly urothelial carcinoma of the upper tract.
1. Positive biopsy for high grade tumor
2. Selective upper tract positive cytology
3. Micturition positive cytology (if there is no bladder cancer simultaneously);B. Radiological defined UTUC: patients with UTUC cT2-T4, N0-M0 (TNM classification). Criteria must be defined by radiologists;Pelvic of calyx tumor:
1. Absence of fat between pelvis and kidney
2. Evidence of parenchymal invasion
3. Growing of tumour out of the renal pelvis
4. Tumor >1 cm;Upper 2/3 of ureter:
1. growing of the tumour out of the ureter
2. dilation grade 3-4
3. tumor >1 cm

Exclusion Criteria

-Clinical suspicion of non-muscle invasive UTUC
-Metastatic urothelial carcinoma for the renal pelvis or upper 2/3 of the ureter
-Radiological positive lymph nodes in the retroperitoneal region

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint/analysis:<br /><br>Recurrence free survival at five-year postoperative. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Incidence of lymph node metastases, local recurrence and/or distant metastasis,<br /><br>cancer specific and overall survival at one, three and five-year postoperative.<br /><br>Complications rate according to Clavien classification within the first thirty<br /><br>days postoperatively [9].<br /><br><br /><br>Another endpoint/analysis:<br /><br>Multivariate analysis of possible preoperative risk factors for lymph node<br /><br>metastases (tumor size, preoperative urinary cytology, lymph node enlargement<br /><br>on CT, PET-CT positive) and postoperative risk factors for lymph node<br /><br>metastases (stage, grade, tumor diameter, presence of necrosis in the tumor<br /><br>(none; <10%; >10% of total tumor area), number of lymph nodes excised).</p><br>