The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called "Template Lymph Node Dissection," can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. The main questions it aims to answer are:
Do patients who receive template lymph node dissection live longer without their cancer returning (Disease-Free Survival)? Do patients who receive template lymph node dissection live longer overall (Overall Survival)? Is the more extensive lymph node surgery as safe as the limited surgery? Researchers will compare the Template Lymph Node Dissection group to the Limited Node Resection group to see the effects on cancer control and safety.
Participants will:
Be randomly assigned to one of the two surgical groups. Undergo surgery to remove their kidney and the assigned lymph nodes. Attend regular follow-up visits with imaging scans (like CT or MRI) for the first 5 years after surgery to monitor if the cancer returns.
Be followed for their overall survival status for up to 10 years.
Signed informed consent form.
Age > 18 years.
Candidate for radical nephrectomy with or without lymph node dissection.
High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node >1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size >= 10cm; OR hematuria and/or local symptoms.
Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.
Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).
Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.
Preoperative imaging indicates unresectable regional lymph nodes.
Parallel
Template Lymph Node Dissection
Procedure/SurgeryA standardized surgical procedure to remove lymph nodes within defined anatomical boundaries during radical nephrectomy for kidney cancer. For left-sided tumors, this includes tissue anterior and lateral to the aorta from the diaphragmatic crus to the aortic bifurcation. For right-sided tumors, it includes tissue around the vena cava and between the vena cava and aorta from the liver edge to the iliac bifurcation. The renal hilar lymph tissue is always included.
Selective Lymph Node Resection
Procedure/SurgeryA surgical approach during radical nephrectomy for kidney cancer where lymph nodes are removed only if they meet specific criteria: being larger than 1 cm on preoperative CT/MRI scans, or appearing grossly enlarged and suspicious to the surgeon during the operation. If no such nodes are identified, no lymph node dissection is performed.
Disease-Free Survival (DFS)
Time from randomization to the first documented disease recurrence (local, regional, or distant metastasis), occurrence of a second primary renal cell carcinoma, or death from any cause, whichever occurs first.
Overall Survival (OS)
Time from randomization to death from any cause.
Incidence and Severity of Postoperative Complications (Perioperative Safety)
A composite measure to assess the safety of the surgical procedures, including: 1. Incidence and severity of postoperative complications graded by Clavien-Dindo classification. 2. Operative time (minutes). 3. Estimated intraoperative blood loss (milliliters). 4. Length of postoperative hospital stay (days).
Cancer-Specific Survival (CSS)
Time from randomization to death attributable to renal cell carcinoma. Deaths from other causes are censored.
Absolute Number of Retrieved Lymph Nodes per Anatomic Template
The absolute number of lymph nodes retrieved from each of the predefined anatomical template regions: right renal hilum, suprarenal para-caval, infrarenal para-caval, left renal hilum, suprarenal para-aortic, and renal hilar para-aortic.
Pathological Nodal Positivity Rate (pN+%) per Anatomic Template
The pathological nodal positivity rate (calculated as the number of positive nodes divided by the total number of retrieved nodes, expressed as a percentage) from each of the predefined anatomical template regions.
Exploration of Biomarkers for Survival
Identification of molecular biomarkers predictive of Disease-Free Survival (DFS), Cancer-Specific Survival (CSS), and Overall Survival (OS) through Bulk-RNA sequencing analysis performed on prospectively collected tumor tissue samples.
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Tianjin Medical University Second Hospital
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Collaborator
Tianjin Third Central Hospital
Collaborator
