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

May 19, 2018 updated by: RenJi Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

504

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijin
      • Beijin, Beijin, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Xuesong Li, M.D
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
          • Jiwei Huang, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine lymph node dissection (LND) during nephroureterectomy
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
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.
Active Comparator: LND for lymph nodes enlargement found before or during surgery
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Peking University First Hospital

Investigators

  • Principal Investigator: Wei Xue, M.D, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Principal Investigator: Liqun Zhou, M.D, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2018

Primary Completion (Anticipated)

February 22, 2023

Study Completion (Anticipated)

February 22, 2023

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 19, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTUC-LND collaboration 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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