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

Primary Purpose

Lymph Node Dissection

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Routine Template-based lymphadenectomy
LND only for lymph nodes enlargement found in preoperative image or during surgery
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymph Node Dissection focused on measuring urothelial cancer, nephroureterectomy, Upper urinary tract

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First HospitalRecruiting
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Routine lymph node dissection (LND) during nephroureterectomy

LND for lymph nodes enlargement found before or during surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disease free survival
Disease free survival rate in the 36 month following nephroureterectomy

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2018
Last Updated
May 19, 2018
Sponsor
RenJi Hospital
Collaborators
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03474926
Brief Title
Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
February 22, 2023 (Anticipated)
Study Completion Date
February 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymph Node Dissection
Keywords
urothelial cancer, nephroureterectomy, Upper urinary tract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine lymph node dissection (LND) during nephroureterectomy
Arm Type
Experimental
Arm Description
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.
Arm Title
LND for lymph nodes enlargement found before or during surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Routine Template-based lymphadenectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
LND only for lymph nodes enlargement found in preoperative image or during surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Disease free survival
Description
Disease free survival rate in the 36 month following nephroureterectomy
Time Frame
36 month
Secondary Outcome Measure Information:
Title
Cancer specific survival
Description
Cancer specific survival rate in the 36 month following nephroureterectomy
Time Frame
36 month
Title
Overall survival
Description
Overall survival rate in the 36 month following nephroureterectomy
Time Frame
36 month
Title
The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
Description
The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
Time Frame
36 month
Title
Perioperative complications rate
Description
Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification
Time Frame
90 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jiwei huang, M.D.
Phone
8613651682825
Email
huangjiwei@renji.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xue, M.D
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liqun Zhou, M.D
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijin
State/Province
Beijin
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuesong Li, M.D
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwei Huang, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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