Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract

Study Overview
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Brief Summary
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Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.

Official Title
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Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement Found in Preoperative Imaging or During Surgery Undergoing Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carcinoma

Conditions
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Lymph Node Dissection

Intervention / Treatment
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* Procedure: Routine Template-based lymphadenectomy
* Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically diagnosed with upper tract urothelial carcinoma have no distant metastasis have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2 expected to receive radical nephroureterectomy Exclusion Criteria: a prior history of bladder cancer administration of neoadjuvant chemotherapy deny to receive long term follow-up patients with contralateral UTUCs patients with synchronous muscle invasive bladder cancer

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine lymph node dissection (LND) during nephroureterectomy<br>Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled en bloc with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue. | Procedure: Routine Template-based lymphadenectomy<br>* Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled en bloc with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue.<br>|
| Active Comparator: LND for lymph nodes enlargement found before or during surgery<br>LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery. | Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery<br>* LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival rate in the 36 month following nephroureterectomy | 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer specific survival | Cancer specific survival rate in the 36 month following nephroureterectomy | 36 month | 
| Overall survival | Overall survival rate in the 36 month following nephroureterectomy | 36 month | 
| The recurrence rate of bladder cancer in the 36 month following nephroureterectomy | The recurrence rate of bladder cancer in the 36 month following nephroureterectomy | 36 month | 
| Perioperative complications rate | Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classiﬁcation | 90 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urothelial cancer, nephroureterectomy, Upper urinary tract