Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcin… (NCT07321197) | Clinical Trial Compass
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Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC)
China220 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* renal tumors or known hereditary RCC syndrome.
* Diagnosis of any other active malignancy within the past 5 years.
* Active autoimmune disease or history of autoimmune disease.
* Use of immunosuppressive agents within 2 weeks prior to enrollment.
* Poorly controlled cardiac or cl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease-Free Survival (DFS)
Timeframe: From randomization until the first occurrence of disease recurrence, second primary cancer, or death from any cause, assessed up to 10 years.
2
Overall Survival (OS)
Timeframe: From randomization until death from any cause, assessed up to 10 years.
3
Incidence and Severity of Postoperative Complications (Perioperative Safety)
Timeframe: From the date of surgery until 30 days post-operation.