Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC): A Randomized Clinical Trial

NCT07321197 | Not Yet Recruiting

• 1 other identifier: TLND-RCC
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Keywords

Template Lymph Node Dissection; High-Risk Neoplasm; Randomized Controlled Trial; Surgical Oncology

Outcome Measures

Primary Outcomes (3)

• 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.

  From randomization until the first occurrence of disease recurrence, second primary cancer, or death from any cause, assessed up to 10 years.

• Overall Survival (OS)

  Time from randomization to death from any cause.

  From randomization until death from any cause, assessed up to 10 years.

• 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).

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

Secondary Outcomes (4)

• Cancer-Specific Survival (CSS)

  From randomization until death from kidney cancer, assessed up to 10 years.

• Anatomic Lymph Node Mapping and Metastasis Rate

  Assessed on the surgical pathology report, immediately after surgery (within approximately 4 weeks post-operation).

• Exploration of Biomarkers for Survival

  Biomarker analysis will be conducted after sufficient clinical outcome data (DFS/OS events) are available, estimated to be 5 years after study start.

• Predictive Nomogram for Lymph Node Metastasis

  Model development and internal validation will be performed after complete recruitment and surgical pathology data are available for all participants, estimated to be 3 years after study start.

Study Arms (2)

Template Lymph Node Dissection

EXPERIMENTAL

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.

Procedure: Template Lymph Node Dissection

Selective Lymph Node Resection

ACTIVE COMPARATOR

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.

Procedure: Selective Lymph Node Resection

Interventions

Template Lymph Node Dissection PROCEDURE

A 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.

Template Lymph Node Dissection

Selective Lymph Node Resection PROCEDURE

A 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.

Selective Lymph Node Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. Bilateral 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 clinical symptoms. Coagulopathy or bleeding tendency. Active gastrointestinal conditions with risk of bleeding or perforation. History of significant bleeding or thromboembolic events within specified timeframes.
• Active infection or unexplained fever \>38.5°C. Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.
• History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.
• Known immunodeficiency or active hepatitis. Participation in another clinical trial within 1 month. Known history of drug abuse or alcohol addiction. Inability or unwillingness to bear the self-paid portion of examination and treatment costs.
• Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Tianjin Third Central Hospital: collaborator
• Sun Yat-Sen University Cancer Center: collaborator
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator

Related Publications (22)

• Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.

  PMID: 39817679 BACKGROUND

• Capitanio U, Matloob R, Suardi N, Abdollah F, Castiglione F, Di Trapani D, Russo A, Briganti A, Carenzi C, Salonia A, Montorsi F, Rigatti P, Bertini R. The extent of lymphadenectomy does affect cancer specific survival in pathologically confirmed T4 renal cell carcinoma. Urologia. 2012 Apr-Jun;79(2):109-15. doi: 10.5301/RU.2012.9255.

  PMID: 22610843 BACKGROUND

• Capitanio U, Suardi N, Matloob R, Roscigno M, Abdollah F, Di Trapani E, Moschini M, Gallina A, Salonia A, Briganti A, Montorsi F, Bertini R. Extent of lymph node dissection at nephrectomy affects cancer-specific survival and metastatic progression in specific sub-categories of patients with renal cell carcinoma (RCC). BJU Int. 2014 Aug;114(2):210-5. doi: 10.1111/bju.12508. Epub 2014 May 22.

  PMID: 24854206 BACKGROUND

• Whitson JM, Harris CR, Reese AC, Meng MV. Lymphadenectomy improves survival of patients with renal cell carcinoma and nodal metastases. J Urol. 2011 May;185(5):1615-20. doi: 10.1016/j.juro.2010.12.053. Epub 2011 Mar 21.

  PMID: 21419453 BACKGROUND

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.

  PMID: 35020204 BACKGROUND

• Crispen PL, Breau RH, Allmer C, Lohse CM, Cheville JC, Leibovich BC, Blute ML. Lymph node dissection at the time of radical nephrectomy for high-risk clear cell renal cell carcinoma: indications and recommendations for surgical templates. Eur Urol. 2011 Jan;59(1):18-23. doi: 10.1016/j.eururo.2010.08.042. Epub 2010 Sep 15.

  PMID: 20933322 BACKGROUND

• Motzer RJ, Jonasch E, Agarwal N, Alva A, Baine M, Beckermann K, Carlo MI, Choueiri TK, Costello BA, Derweesh IH, Desai A, Ged Y, George S, Gore JL, Haas N, Hancock SL, Kapur P, Kyriakopoulos C, Lam ET, Lara PN, Lau C, Lewis B, Madoff DC, Manley B, Michaelson MD, Mortazavi A, Nandagopal L, Plimack ER, Ponsky L, Ramalingam S, Shuch B, Smith ZL, Sosman J, Dwyer MA, Gurski LA, Motter A. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Jan;20(1):71-90. doi: 10.6004/jnccn.2022.0001.

  PMID: 34991070 BACKGROUND

• Hutterer GC, Patard JJ, Perrotte P, Ionescu C, de La Taille A, Salomon L, Verhoest G, Tostain J, Cindolo L, Ficarra V, Artibani W, Schips L, Zigeuner R, Mulders PF, Valeri A, Chautard D, Descotes JL, Rambeaud JJ, Mejean A, Karakiewicz PI. Patients with renal cell carcinoma nodal metastases can be accurately identified: external validation of a new nomogram. Int J Cancer. 2007 Dec 1;121(11):2556-61. doi: 10.1002/ijc.23010.

  PMID: 17691107 BACKGROUND

• Babaian KN, Kim DY, Kenney PA, Wood CG Jr, Wong J, Sanchez C, Fang JE, Gerber JA, Didic A, Wahab A, Golla V, Torres C, Tamboli P, Qiao W, Matin SF, Wood CG, Karam JA. Preoperative predictors of pathological lymph node metastasis in patients with renal cell carcinoma undergoing retroperitoneal lymph node dissection. J Urol. 2015 Apr;193(4):1101-7. doi: 10.1016/j.juro.2014.10.096. Epub 2014 Oct 25.

  PMID: 25390078 BACKGROUND

• Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Chang YH, Lee JL, Sarwar N, Haas NB, Gurney H, Sawrycki P, Mahave M, Gross-Goupil M, Zhang T, Burke JM, Doshi G, Melichar B, Kopyltsov E, Alva A, Oudard S, Topart D, Hammers H, Kitamura H, McDermott DF, Silva A, Winquist E, Cornell J, Elfiky A, Burgents JE, Perini RF, Powles T; KEYNOTE-564 Investigators. Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma. N Engl J Med. 2024 Apr 18;390(15):1359-1371. doi: 10.1056/NEJMoa2312695.

  PMID: 38631003 BACKGROUND

• Margulis V, Wood CG. The role of lymph node dissection in renal cell carcinoma: the pendulum swings back. Cancer J. 2008 Sep-Oct;14(5):308-14. doi: 10.1097/PPO.0b013e31818675eb.

  PMID: 18836335 BACKGROUND

• Gershman B, Moreira DM, Thompson RH, Boorjian SA, Lohse CM, Costello BA, Cheville JC, Leibovich BC. Perioperative Morbidity of Lymph Node Dissection for Renal Cell Carcinoma: A Propensity Score-based Analysis. Eur Urol. 2018 Mar;73(3):469-475. doi: 10.1016/j.eururo.2017.10.020. Epub 2017 Nov 11.

  PMID: 29132713 BACKGROUND

• Bex A, Ghanem YA, Albiges L, Bonn S, Campi R, Capitanio U, Dabestani S, Hora M, Klatte T, Kuusk T, Lund L, Marconi L, Palumbo C, Pignot G, Powles T, Schouten N, Tran M, Volpe A, Bedke J. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2025 Update. Eur Urol. 2025 Jun;87(6):683-696. doi: 10.1016/j.eururo.2025.02.020. Epub 2025 Mar 20.

  PMID: 40118739 BACKGROUND

• Pantuck AJ, Zisman A, Dorey F, Chao DH, Han KR, Said J, Gitlitz BJ, Figlin RA, Belldegrun AS. Renal cell carcinoma with retroperitoneal lymph nodes: role of lymph node dissection. J Urol. 2003 Jun;169(6):2076-83. doi: 10.1097/01.ju.0000066130.27119.1c.

  PMID: 12771723 BACKGROUND

• Gershman B, Thompson RH, Moreira DM, Boorjian SA, Tollefson MK, Lohse CM, Costello BA, Cheville JC, Leibovich BC. Radical Nephrectomy With or Without Lymph Node Dissection for Nonmetastatic Renal Cell Carcinoma: A Propensity Score-based Analysis. Eur Urol. 2017 Apr;71(4):560-567. doi: 10.1016/j.eururo.2016.09.019. Epub 2016 Sep 24.

  PMID: 27671144 BACKGROUND

• Zi H, Liu MY, Luo LS, Huang Q, Luo PC, Luan HH, Huang J, Wang DQ, Wang YB, Zhang YY, Yu RP, Li YT, Zheng H, Liu TZ, Fan Y, Zeng XT. Global burden of benign prostatic hyperplasia, urinary tract infections, urolithiasis, bladder cancer, kidney cancer, and prostate cancer from 1990 to 2021. Mil Med Res. 2024 Sep 18;11(1):64. doi: 10.1186/s40779-024-00569-w.

  PMID: 39294748 BACKGROUND

• Blom JH, van Poppel H, Marechal JM, Jacqmin D, Schroder FH, de Prijck L, Sylvester R; EORTC Genitourinary Tract Cancer Group. Radical nephrectomy with and without lymph-node dissection: final results of European Organization for Research and Treatment of Cancer (EORTC) randomized phase 3 trial 30881. Eur Urol. 2009 Jan;55(1):28-34. doi: 10.1016/j.eururo.2008.09.052. Epub 2008 Oct 1.

  PMID: 18848382 BACKGROUND

• Capitanio U, Becker F, Blute ML, Mulders P, Patard JJ, Russo P, Studer UE, Van Poppel H. Lymph node dissection in renal cell carcinoma. Eur Urol. 2011 Dec;60(6):1212-20. doi: 10.1016/j.eururo.2011.09.003. Epub 2011 Sep 13.

  PMID: 21940096 BACKGROUND

• Ngai M, Chandrasekar T, Bratslavsky G, Goldberg H. The Current Role of Lymph Node Dissection in Nonmetastatic Localized Renal Cell Carcinoma. J Clin Med. 2023 May 29;12(11):3732. doi: 10.3390/jcm12113732.

  PMID: 37297925 BACKGROUND

• Marshall FF, Powell KC. Lymphadenectomy for renal cell carcinoma: anatomical and therapeutic considerations. J Urol. 1982 Oct;128(4):677-81. doi: 10.1016/s0022-5347(17)53132-8. No abstract available.

  PMID: 7143582 BACKGROUND

• Blute ML, Leibovich BC, Cheville JC, Lohse CM, Zincke H. A protocol for performing extended lymph node dissection using primary tumor pathological features for patients treated with radical nephrectomy for clear cell renal cell carcinoma. J Urol. 2004 Aug;172(2):465-9. doi: 10.1097/01.ju.0000129815.91927.85.

  PMID: 15247704 BACKGROUND

• Capitanio U, Leibovich BC. The rationale and the role of lymph node dissection in renal cell carcinoma. World J Urol. 2017 Apr;35(4):497-506. doi: 10.1007/s00345-016-1886-3. Epub 2016 Jun 30.

  PMID: 27364520 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Changyi Quan, MD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shimiao Zhu, MD, PhD

CONTACT

+86 88328607; zhushimiao@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2033
• Last Updated: January 6, 2026

Record last verified: 2025-12