Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 26 for:    upper tract urothelial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474926
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Peking University First Hospital
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Lymph Node Dissection Procedure: Routine Template-based lymphadenectomy Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : February 22, 2023
Estimated Study Completion Date : February 22, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 36 month ]
    Disease free survival rate in the 36 month following nephroureterectomy


Secondary Outcome Measures :
  1. Cancer specific survival [ Time Frame: 36 month ]
    Cancer specific survival rate in the 36 month following nephroureterectomy

  2. Overall survival [ Time Frame: 36 month ]
    Overall survival rate in the 36 month following nephroureterectomy

  3. 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

  4. Perioperative complications rate [ Time Frame: 90 day ]
    Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474926


Contacts
Layout table for location contacts
Contact: jiwei huang, M.D. 8613651682825 huangjiwei@renji.com

Locations
Layout table for location information
China, Beijin
Peking University First Hospital Recruiting
Beijin, Beijin, China, 100034
Contact: Xuesong Li, M.D         
China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200123
Contact: Jiwei Huang, M.D         
Sponsors and Collaborators
RenJi Hospital
Peking University First Hospital
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03474926     History of Changes
Other Study ID Numbers: UTUC-LND collaboration 1
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
urothelial cancer
nephroureterectomy
Upper urinary tract
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms