Radical Nephroureterectomy With vs Without Template Lymph Node Dissection in High-Risk Upper Tract Urothelial Carcinoma (T-LND UTUC)

ConditionsUpper Tract Urothelial Carcinoma Lymph Node Dissection

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorTianjin Medical University Second Hospital

About this trial

The goal of this clinical trial is to learn if adding a template lymph node dissection (TLND) to the standard surgery for upper tract urothelial cancer (UTUC) can improve patient survival and prevent the cancer from recurrence. The main questions it aims to answer are:

Do patients who receive standard surgery with LND live longer without their cancer returning? Is adding LND safe, and how does it affect surgery-related complications? Researchers will compare the group receiving standard surgery plus LND to the group receiving standard surgery alone to see if adding LND is more effective.

Participants will:

Be randomly assigned to one of the two surgical groups. Undergo their assigned surgery and recover in the hospital. Attend regular follow-up visits for checkups and scans for 5 years to monitor for cancer recurrence, with the possibility of long-term follow-up extending to 10 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent form (ICF).

Age > 18 years at the time of ICF signing.

Clinical diagnosis of unilateral Upper Tract Urothelial Carcinoma (UTUC) by imaging (enhanced CT or MRI) and/or ureteroscopic biopsy/urinary cytology, and scheduled to undergo Radical Nephroureterectomy (RNU).

Locally advanced: Preoperative imaging assessed as cT2 stage or higher (i.e., tumor invades muscularis propria or deeper).

Disqualifiers

Previous receipt of any anti-tumor therapy for UTUC, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy.

History or concurrent presence of muscle-invasive bladder urothelial carcinoma.

Preoperative imaging assesses regional lymph nodes as unresectable: lymph nodes fused into a massive conglomerate, or fully encasing the abdominal aorta/inferior vena cava/pelvic vessels preventing safe separation.

Known bilateral UTUC or hereditary diseases that definitively increase the risk of contralateral upper tract tumors, such as Lynch Syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

Template Lymph Node Dissection
Procedure/Surgery
A systematic and anatomic-based lymph node dissection performed during radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). The dissection boundaries are strictly defined by a pre-specified template according to the primary tumor location: renal hilum+para-aortic (left hilar and paraaortic) or renal hilum+para-caval (right hilar, paracaval, and interaortocaval) for renal pelvis/upper ureter; extended to common/external iliac for mid-ureter; and pelvic (common, external, internal iliac, and obturator) for lower ureter. The goal is potential therapeutic benefit by removing nodal metastatic disease.
Selective Lymph Node Resection
Procedure/Surgery
A diagnostic procedure performed during radical nephroureterectomy (RNU). It does not involve a systematic template dissection. The surgeon will only remove intraoperatively identified suspicious and radiographic lymphadenopathy (\>1 cm in the short-axis diameter). The primary goal is pathological staging rather than therapeutic clearance of a nodal basin.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: RNU + Template Lymph Node DissectionExperimental treatment 1 intervention

Group B: RNU + Selective Lymph Node ResectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Disease-Free Survival (DFS)

Time from randomization to the first documented occurrence of disease recurrence (local, regional nodal, or distant metastasis), new urothelial carcinoma in the contralateral upper tract or bladder, or death from any cause, whichever occurs first.

Time frame

From date of randomization until the date of first documented progression, recurrence, or death from any cause, assessed up to 5 years. (Assessments: every 3 months for the first 2 years, then every 6 months for years 3-5.)

Overall Survival (OS)

Time from randomization to death from any cause.

Time frame

From date of randomization until the date of death from any cause, assessed up to 5 years. (Assessments: every 3 months.)

Incidence and Severity of Postoperative Complications (Perioperative Safety)

A composite measure to assess the safety of the surgical procedures, including: Incidence and severity of postoperative complications graded by Clavien-Dindo classification. Operative time (minutes). Estimated intraoperative blood loss (milliliters). Length of postoperative hospital stay (days).

Time frame

From the date of surgery until 30 days post-operation.

Secondary outcomes

Non-Urothelial Tract Recurrence-Free Survival (NU-RFS)

Time from randomization to the first documented recurrence at a local site, regional lymph nodes, distant metastasis, or death from any cause, whichever occurs first.

Time frame

From date of randomization until the date of first documented non-urothelial recurrence or death, assessed up to 5 years. (Assessments: every 3 months for the first 2 years, then every 6 months for years 3-5.)

Intravesical Recurrence-Free Survival (IFS)

Time from randomization to the first documented occurrence of new urothelial carcinoma in the bladder or contralateral upper tract, or death from any cause, whichever occurs first.

Time frame

From date of randomization until the date of first documented intravesical recurrence or death, assessed up to 5 years. (Assessments: cystoscopy every 6 months for the first 2 years, then as per protocol.)

Cancer-Specific Survival (CSS)

Time from randomization to death attributable to urothelial carcinoma.

Time frame

Time Frame: From date of randomization until the date of death due to urothelial carcinoma, assessed up to 5 years. (Assessments: every 3 months.)

Lymph Node Metastasis Map

The distribution and positive rate (pN+%) of lymph node metastases, mapped according to the predefined template dissection locations for different primary tumor sites (renal pelvis/upper ureter, mid-ureter, lower ureter).

Time frame

At time of surgery (from final pathological report, approximately 4 weeks post-operation)

Other outcomes

Prognostic Molecular Biomarker Expression Levels

Evaluation of prognostic molecular biological biomarkers (measured by transcript expression levels) through Bulk RNA-sequencing of prospectively collected tumor tissues.

Time frame

Tumor tissue samples are collected at the time of surgery. Biomarker analysis (Bulk RNA-seq) is performed after sample accrual, with the analysis period extending through study completion (up to 10 years).

Nomogram for Prediction of Lymph Node Metastasis

Development of a predictive nomogram for lymph node metastasis based on prospectively collected clinical data, CT radiomics features, tumor size/location, and lymph node characteristics.

Time frame

Baseline clinical and CT radiomic data are collected preoperatively. Model development and validation are performed after data accrual is sufficient, with the analysis period extending through study completion (up to 10 years).