NCT03474926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
504

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

February 27, 2018

Last Update Submit

May 19, 2018

Conditions

Lymph Node Dissection

Keywords

urothelial cancernephroureterectomyUpper urinary tract

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    Disease free survival rate in the 36 month following nephroureterectomy

    36 month

Secondary Outcomes (4)

  • 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 Arms (2)

Routine lymph node dissection (LND) during nephroureterectomy

EXPERIMENTAL

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

LND for lymph nodes enlargement found before or during surgery

ACTIVE COMPARATOR

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

Interventions

Routine Template-based lymphadenectomyPROCEDURE

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.

Routine lymph node dissection (LND) during nephroureterectomy
LND only for lymph nodes enlargement found in preoperative image or during surgeryPROCEDURE

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

LND for lymph nodes enlargement found before or during surgery

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijin, Beijin, 100034, China

RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Study Officials

  • Wei Xue, M.D

    Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

  • Liqun Zhou, M.D

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jiwei huang, M.D.

CONTACT

8613651682825huangjiwei@renji.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 23, 2018

Study Start

February 22, 2018

Primary Completion

February 22, 2023

Study Completion

February 22, 2023

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CN(2)