Bladder Cancer Clinical Trial
Official title:
Prognostic Effect of Whether Doing Lymph Node Dissection During Radical Cystectomy for High-risk Non-muscular Invasive Bladder Cancer: a Prospective Study
NCT number | NCT05123625 |
Other study ID # | 2021-SR-291 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | June 30, 2028 |
There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or cystoscopic findings of multiple, tumor diameter greater than 3 cm; and VI-RADS score of 1 or 2; and no enlarged lymph nodes detected by MRI. 2. Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent TaG1G2/low-grade bladder cancer patients with >3 cm in diameter. And no enlarged lymph nodes detected on MRI. 3. Benefit from radical cystectomy as assessed by the investigator. 4. Meeting the indications for the procedure: a) absolute neutrophil count = 1.5 *109/L; b) platelets = 100 *109/L; c) hemoglobin = 90 g/L; d) international normalized ratio or activated partial thromboplastin time = 1.5 upper limit of normal (ULN); e) calculated creatinine clearance = 1 ml/s f) serum total bilirubin = 1.5 * ULN; g) AST, ALT and alkaline phosphatase = 2.5 * ULN; h) cardiopulmonary function suggestive of tolerance to major abdominal surgery. 5. No previous history of tumor, lymph node dissection, or immune system-related disease. 6. Age 18 to 75 years. 7. No neoadjuvant therapy. 8. ECOG physical status 0 or 1. 9. Voluntary participation in this trial, ability to provide written informed consent, and understanding and agreement to comply with the requirements of this study and the evaluation schedule. Exclusion Criteria: 1. Patients with bladder cancer = T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI; 2. The investigator assessed patients who could not tolerate radical cystectomy; 3. Previous systemic chemotherapy or immunotherapy; 4. The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants; 5. Had undergone major surgery or major trauma within 28 days before enrollment; 6. Received live vaccine within 28 days before enrollment; 7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment; 8. Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment; 9. Participating in other clinical studies. |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Abdollah F, Sun M, Schmitges J, Djahangirian O, Tian Z, Jeldres C, Perrotte P, Shariat SF, Montorsi F, Karakiewicz PI. Stage-specific impact of pelvic lymph node dissection on survival in patients with non-metastatic bladder cancer treated with radical cystectomy. BJU Int. 2012 Apr;109(8):1147-54. doi: 10.1111/j.1464-410X.2011.10482.x. Epub 2011 Aug 24. — View Citation
Babjuk M, Burger M, Compérat EM, Gontero P, Mostafid AH, Palou J, van Rhijn BWG, Rouprêt M, Shariat SF, Sylvester R, Zigeuner R, Capoun O, Cohen D, Escrig JLD, Hernández V, Peyronnet B, Seisen T, Soukup V. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update. Eur Urol. 2019 Nov;76(5):639-657. doi: 10.1016/j.eururo.2019.08.016. Epub 2019 Aug 20. Review. — View Citation
Brössner C, Pycha A, Toth A, Mian C, Kuber W. Does extended lymphadenectomy increase the morbidity of radical cystectomy? BJU Int. 2004 Jan;93(1):64-6. — View Citation
Bruins HM, Huang GJ, Cai J, Skinner DG, Stein JP, Penson DF. Clinical outcomes and recurrence predictors of lymph node positive urothelial cancer after cystectomy. J Urol. 2009 Nov;182(5):2182-7. doi: 10.1016/j.juro.2009.07.017. Epub 2009 Sep 15. — View Citation
Bruins HM, Skinner EC, Dorin RP, Ahmadi H, Djaladat H, Miranda G, Cai J, Daneshmand S. Incidence and location of lymph node metastases in patients undergoing radical cystectomy for clinical non-muscle invasive bladder cancer: results from a prospective lymph node mapping study. Urol Oncol. 2014 Jan;32(1):24.e13-9. doi: 10.1016/j.urolonc.2012.08.015. Epub 2013 Feb 6. — View Citation
Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25. Review. — View Citation
Chang SS, Bochner BH, Chou R, Dreicer R, Kamat AM, Lerner SP, Lotan Y, Meeks JJ, Michalski JM, Morgan TM, Quale DZ, Rosenberg JE, Zietman AL, Holzbeierlein JM. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline. J Urol. 2017 Sep;198(3):552-559. doi: 10.1016/j.juro.2017.04.086. Epub 2017 Apr 26. Erratum in: J Urol. 2017 Nov;198(5):1175. — View Citation
Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16. Review. — View Citation
Del Giudice F, Barchetti G, De Berardinis E, Pecoraro M, Salvo V, Simone G, Sciarra A, Leonardo C, Gallucci M, Catalano C, Catto JWF, Panebianco V. Prospective Assessment of Vesical Imaging Reporting and Data System (VI-RADS) and Its Clinical Impact on the Management of High-risk Non-muscle-invasive Bladder Cancer Patients Candidate for Repeated Transurethral Resection. Eur Urol. 2020 Jan;77(1):101-109. doi: 10.1016/j.eururo.2019.09.029. Epub 2019 Nov 5. — View Citation
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation
Fragkoulis C, Glykas I, Papadopoulos G, Ntoumas K. Multiparametric MRI in differentiation between muscle invasive and non-muscle invasive urinary bladder cancer with vesical imaging reporting and data system (VI-RADS) application. Br J Radiol. 2020 May 1;93(1109):20200025. doi: 10.1259/bjr.20200025. Epub 2020 Mar 11. — View Citation
Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hübler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19. — View Citation
García-Perdomo HA, Montes-Cardona CE, Guacheta M, Castillo DF, Reis LO. Muscle-invasive bladder cancer organ-preserving therapy: systematic review and meta-analysis. World J Urol. 2018 Dec;36(12):1997-2008. doi: 10.1007/s00345-018-2384-6. Epub 2018 Jun 25. — View Citation
Giacalone NJ, Shipley WU, Clayman RH, Niemierko A, Drumm M, Heney NM, Michaelson MD, Lee RJ, Saylor PJ, Wszolek MF, Feldman AS, Dahl DM, Zietman AL, Efstathiou JA. Long-term Outcomes After Bladder-preserving Tri-modality Therapy for Patients with Muscle-invasive Bladder Cancer: An Updated Analysis of the Massachusetts General Hospital Experience. Eur Urol. 2017 Jun;71(6):952-960. doi: 10.1016/j.eururo.2016.12.020. Epub 2017 Jan 9. — View Citation
Gschwend JE, Heck MM, Lehmann J, Rübben H, Albers P, Wolff JM, Frohneberg D, de Geeter P, Heidenreich A, Kälble T, Stöckle M, Schnöller T, Stenzl A, Müller M, Truss M, Roth S, Liehr UB, Leißner J, Bregenzer T, Retz M. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol. 2019 Apr;75(4):604-611. doi: 10.1016/j.eururo.2018.09.047. Epub 2018 Oct 15. — View Citation
Jeong IG, You D, Kim JW, Song C, Hong JH, Ahn H, Kim CS. Outcomes of single lymph node positive urothelial carcinoma after radical cystectomy. J Urol. 2011 Jun;185(6):2085-90. doi: 10.1016/j.juro.2011.02.056. Epub 2011 Apr 15. — View Citation
Karl A, Carroll PR, Gschwend JE, Knüchel R, Montorsi F, Stief CG, Studer UE. The impact of lymphadenectomy and lymph node metastasis on the outcomes of radical cystectomy for bladder cancer. Eur Urol. 2009 Apr;55(4):826-35. doi: 10.1016/j.eururo.2009.01.004. Epub 2009 Jan 13. Review. — View Citation
Kulkarni GS, Hermanns T, Wei Y, Bhindi B, Satkunasivam R, Athanasopoulos P, Bostrom PJ, Kuk C, Li K, Templeton AJ, Sridhar SS, van der Kwast TH, Chung P, Bristow RG, Milosevic M, Warde P, Fleshner NE, Jewett MAS, Bashir S, Zlotta AR. Propensity Score Analysis of Radical Cystectomy Versus Bladder-Sparing Trimodal Therapy in the Setting of a Multidisciplinary Bladder Cancer Clinic. J Clin Oncol. 2017 Jul 10;35(20):2299-2305. doi: 10.1200/JCO.2016.69.2327. Epub 2017 Apr 14. — View Citation
Lenis AT, Lec PM, Michel J, Brisbane W, Golla V, Sharma V, Gollapudi K, Blumberg J, Chamie K. Predictors of adequate lymph node dissection in patients with non-muscle invasive bladder cancer undergoing radical cystectomy and effect on survival. Urol Oncol. 2020 Oct;38(10):796.e7-796.e14. doi: 10.1016/j.urolonc.2020.04.027. Epub 2020 May 20. — View Citation
Li Y, Diao F, Shi S, Li K, Zhu W, Wu S, Lin T. Computed tomography and magnetic resonance imaging evaluation of pelvic lymph node metastasis in bladder cancer. Chin J Cancer. 2018 Jan 26;37(1):3. doi: 10.1186/s40880-018-0269-0. — View Citation
Papalia R, Simone G, Grasso R, Augelli R, Faiella E, Guaglianone S, Cazzato R, Del Vescovo R, Ferriero M, Zobel B, Gallucci M. Diffusion-weighted magnetic resonance imaging in patients selected for radical cystectomy: detection rate of pelvic lymph node metastases. BJU Int. 2012 Apr;109(7):1031-6. doi: 10.1111/j.1464-410X.2011.10446.x. Epub 2011 Aug 25. — View Citation
Perera M, McGrath S, Sengupta S, Crozier J, Bolton D, Lawrentschuk N. Pelvic lymph node dissection during radical cystectomy for muscle-invasive bladder cancer. Nat Rev Urol. 2018 Nov;15(11):686-692. doi: 10.1038/s41585-018-0066-1. Review. — View Citation
Raj GV, Herr H, Serio AM, Donat SM, Bochner BH, Vickers AJ, Dalbagni G. Treatment paradigm shift may improve survival of patients with high risk superficial bladder cancer. J Urol. 2007 Apr;177(4):1283-6; discussion 1286. — View Citation
Ueno Y, Takeuchi M, Tamada T, Sofue K, Takahashi S, Kamishima Y, Hinata N, Harada K, Fujisawa M, Murakami T. Diagnostic Accuracy and Interobserver Agreement for the Vesical Imaging-Reporting and Data System for Muscle-invasive Bladder Cancer: A Multireader Validation Study. Eur Urol. 2019 Jul;76(1):54-56. doi: 10.1016/j.eururo.2019.03.012. Epub 2019 Mar 26. — View Citation
Witjes JA, Bruins HM, Cathomas R, Compérat EM, Cowan NC, Gakis G, Hernández V, Linares Espinós E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimäe E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29. Review. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Complication rate | Complication rate after surgery | through study completion, an average of 1 year | |
Primary | PFS | progression-free survival | 5 years after surgery | |
Secondary | OS | Overall Survival | 5 years after surgery |
Status | Clinical Trial | Phase | |
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