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.
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