Skip to main content
Clinical Trials/NCT03474926
NCT03474926
Unknown
Phase 2

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

RenJi Hospital2 sites in 1 country504 target enrollmentFebruary 22, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Lymph Node Dissection
Sponsor
RenJi Hospital
Enrollment
504
Locations
2
Primary Endpoint
Disease free survival
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2018
End Date
February 22, 2023
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Disease free survival

Time Frame: 36 month

Disease free survival rate in the 36 month following nephroureterectomy

Secondary Outcomes

  • Cancer specific survival(36 month)
  • Overall survival(36 month)
  • The recurrence rate of bladder cancer in the 36 month following nephroureterectomy(36 month)
  • Perioperative complications rate(90 day)

Study Sites (2)

Loading locations...

Similar Trials