Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement in Preoperative Imaging During Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carc

Condition: Lymph Node Dissection

Intervention:

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

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03474926

Sponsor: RenJi Hospital

Primary Outcome Measures:

• Measure: Disease free survival
• Time Frame: 36 month
• Safety Issue:

Secondary Outcome Measures:

• Measure: Cancer specific survival
• Time Frame: 36 month
• Safety Issue:
• Measure: Overall survival
• Time Frame: 36 month
• Safety Issue:
• Measure: The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
• Time Frame: 36 month
• Safety Issue:
• Measure: Perioperative complications rate
• Time Frame: 90 day
• Safety Issue:

Estimated Enrollment: 504

Study Start Date: February 22, 2018

Phase: Phase 2

Eligibility:

• Age: minimum 15 Years maximum 80 Years
• Gender: All

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

Contact:

• jiwei huang, M.D.
• huangjiwei@renji.com
• 8613651682825

Locations:

• Peking University First Hospital
• Beijin Beijin 100034 China

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University
• Shanghai Shanghai 200123 China

View trial on ClinicalTrials.gov