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A multi-institutional prospective randomized controlled study investigating the outcome and safety of the lymphadenectomy plus radical nephroureterectomy for upper tract urothelial cancer

A multi-institutional prospective randomized controlled study investigating the outcome and safety of the lymphadenectomy plus radical nephroureterectomy for upper tract urothelial cancer - LYNUC study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020506
Enrollment
204
Registered
2016-01-08
Start date
2016-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper tract urothelial carcinoma

Interventions

Intervention Group: In addition to standard open or laparoscopic radical nephroureterectomy, regional lymphadenectomy of the area defined as follows will be performed. Left: Left side of the para-ao

Sponsors

Department of Urology, Akita University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet the criteria as described below will be included: 1.Are presenting with an upper tract urothelial carcinoma located in the renal pelvis or ureter proximal to the lower renal pole level without lymph node metastasis that is diagnosed using CT scan and cytology. 2.Are presenting with a curable disease by radical nephroureterectomy. 3.Are presenting with no lymph-node swelling treated by the neo-adjuvant chemotherapies and is diagnosed to be a curable disease by radical nephroureterectomy. 4.Are presenting with an initial diagnosis of urothelial carcinoma. 5.Are presenting with ECOG performance status 0-1. 6.Agree with the protocol with signed informed consent

Exclusion criteria

Exclusion criteria: Patients who meet the criteria below will be excluded: 1.Are presenting with cTa or cTis tumor. 2.Are presenting with an upper tract urothelial carcinomas located in the ureter distal to the lower renal pole level. 3.Are presenting with cN1 or cN2 disease and lymphadenectomy is strongly recommended. 4.Are presenting with distant metastases. 5.Have histories bladder cancer or have simultaneous bladder cancer.

Design outcomes

Primary

MeasureTime frame
5-year recurrence-free survival

Secondary

MeasureTime frame
5-year overall survival, 5-year cancer-specific survival, location of recurrences, perioperative complications

Countries

Japan

Contacts

Public ContactShintaro Narita

Akita University Graduate School of Medicine Urology

narishin@doc.med.akita-u.ac.jp018-884-6156

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026