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

• Sponsor: RenJi Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03474926
• Collaborator: Peking University First Hospital (Other)
• Enrollment: 504
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site: 252
• Patients Per Site Per Month: 4.2

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 22, 2018
• Anticipated Primary Completion Date: Feb 22, 2023
• Anticipated Study Completion Date: Feb 22, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disease free survival [36 month]

   Disease free survival rate in the 36 month following nephroureterectomy

Secondary Outcome Measures

1. Cancer specific survival [36 month]

   Cancer specific survival rate in the 36 month following nephroureterectomy

2. Overall survival [36 month]

   Overall survival rate in the 36 month following nephroureterectomy

3. The recurrence rate of bladder cancer in the 36 month following nephroureterectomy [36 month]

   The recurrence rate of bladder cancer in the 36 month following nephroureterectomy

4. Perioperative complications rate [90 day]

   Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijin	Beijin	China	100034
2	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200123

Sponsors and Collaborators

• RenJi Hospital
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT03474926
• Other Study ID Numbers: UTUC-LND collaboration 1
• First Posted: Mar 23, 2018
• Last Update Posted: May 22, 2018
• Last Verified: May 1, 2018

• 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: Carcinoma

Study Results

No Results Posted as of May 22, 2018