Nephrectomy Clinical Trials

Clinical trials related to Nephrectomy Procedure

Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

• Measurable disease as per RECIST v1.1.

• ECOG performance status of 0 or 1.

• Adequate bone marrow, renal, and hepatic function.

• For women and men of childbearing potential, agreement to use effective contraception during the study period.

Locations

Other Locations

China

Tianjin Medical University Second Hospital

RECRUITING

Tianjin

Contact Information

Primary

Shimiao Zhu, MD, PhD

zhushimiao@tmu.edu.cn

+86 88328607

Time Frame

Start Date: 2025-09-01

Estimated Completion Date: 2033-09-30

Participants

Target number of participants: 220

Treatments

Experimental: Template Lymph Node Dissection

Patients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach based on the surgeon's expertise) combined with a standardized template lymph node dissection.~The template lymph node dissection is defined as follows:~For Left-sided Tumors: Removal of lymphatic tissue anterior and lateral to the abdominal aorta, extending from the diaphragmatic crus superiorly to the aortic bifurcation inferiorly, including the renal hilar lymph tissue.~For Right-sided Tumors: Removal of lymphatic tissue surrounding the inferior vena cava and in the interaortocaval space, extending from the liver edge of the vena cava superiorly to the iliac vein bifurcation inferiorly, including the renal hilar lymph tissue.

Active_comparator: Selective Lymph Node Resection

Patients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach). In this arm, only lymph nodes that are identified as \>1 cm in the short axis on preoperative cross-sectional imaging (CT/MRI) OR are grossly enlarged and suspicious during the surgeon's intraoperative assessment will be resected. If no such nodes are identified preoperatively or intraoperatively, no formal lymph node dissection is performed.

Related Therapeutic Areas

Renal Cell Carcinoma (RCC)

Nephrectomy

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