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

Lymph Node Dissection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03474926
• Other study ID #: UTUC-LND collaboration 1
• Status: Recruiting
• Phase: Phase 2
• Start date: February 22, 2018
• Est. completion date: February 22, 2023

Study information

• Verified date: May 2018
• Source: RenJi Hospital
• Contact: jiwei huang, M.D.
• Phone: 8613651682825
• Email: huangjiwei[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: February 22, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Dissection

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijin	Beijin
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	Disease free survival rate in the 36 month following nephroureterectomy	36 month
Secondary	Cancer specific survival	Cancer specific survival rate in the 36 month following nephroureterectomy	36 month
Secondary	Overall survival	Overall survival rate in the 36 month following nephroureterectomy	36 month
Secondary	The recurrence rate of bladder cancer in the 36 month following nephroureterectomy	The recurrence rate of bladder cancer in the 36 month following nephroureterectomy	36 month
Secondary	Perioperative complications rate	Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classi?cation	90 day