Clinical trial · Interventional
Lymphadenectomy in Urothelial Carcinoma
Lymphadenectomy in Urothelial Carcinoma in the Renal Pelvis and Ureter
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow inclusions
Summary
Brief summary (as posted)
Two out of three tumours in the upper urinary tract are located in the renal pelvis. Muscle-invasive urothelial carcinoma is probably more common among tumours in the upper urinary tract compared to tumours in the urinary bladder. Thus, muscle-invasive tumours represent approximately 45 % of renal pelvic tumours compared to 25 % of tumours within the urinary bladder. As in the bladder, lymph node metastases are rare in non-muscle invasive disease. Information regarding indications, extent and possible curative potential is currently lacking for lymphadenectomy in conjunction with nephroureterectomy for urothelial carcinoma in the upper urinary tract (UUTUC). There are, however, retrospective series with survival data for patients with lymph node metastasis that report long term survival after surgery as monotherapy \[4\] with similar survival proportions as in bladder cancer with lymph node metastases after radical cystectomy. A retrospective study from Tokyo was expanded to the only available prospective study, where 68 patients with UUTUC were submitted to template-based lymphadenectomy. Another retrospective study by the same Japanese group, showed that 5-year cancer-specific and recurrence-free survival was significantly higher in the complete lymphadenectomy group than in the incomplete lymphadenectomy or without lymphadenectomy groups. Tanaka N et al. reported recurrence rate after nephroureterectomy without lymphadenectomy at 1 and 3 years were 18.9 and 29.8 %, respectively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ureteral Neoplasms | Ureter Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphadenectomy in conjugation with nephroureterectomy | Procedure | — | UNRESOLVED |
| Nephroureterectomy without lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Nephroureterektomy
- description
- scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy
- interventionNames
- Procedure: Nephroureterectomy without lymphadenectomy
- type
- EXPERIMENTAL
- label
- Nephroureterektomy + Lymphadenectomy
- description
- scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy
- interventionNames
- Procedure: Lymphadenectomy in conjugation with nephroureterectomy
Primary outcomes (1)
- measure
- Recurrence free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age above 18 years 2. Locally advanced high grade urothelial carcinoma in the renal pelvis or upper 2/3 of the ureter (Clinical stage \> T1) 3. Patient with ECOG performance score of 2 and less. 4. Able to give informed consent Exclusion Criteria: 1. Clinical suspicion of non-muscle invasive UUTUC 2. Metastatic urothelial carcinoma for the renal pelvis or upper 2/3 of the ureter 3. Inability to understand written consent forms or give consent
References
Publications (8)
- BACKGROUNDHolmang S, Johansson SL. Bilateral metachronous ureteral and renal pelvic carcinomas: incidence, clinical presentation, histopathology, treatment and outcome. J Urol. 2006 Jan;175(1):69-72; discussion 72-3. doi: 10.1016/S0022-5347(05)00057-1. PMID 16406872
- BACKGROUNDHall MC, Womack S, Sagalowsky AI, Carmody T, Erickstad MD, Roehrborn CG. Prognostic factors, recurrence, and survival in transitional cell carcinoma of the upper urinary tract: a 30-year experience in 252 patients. Urology. 1998 Oct;52(4):594-601. doi: 10.1016/s0090-4295(98)00295-7. PMID 9763077
- BACKGROUNDOlgac S, Mazumdar M, Dalbagni G, Reuter VE. Urothelial carcinoma of the renal pelvis: a clinicopathologic study of 130 cases. Am J Surg Pathol. 2004 Dec;28(12):1545-52. doi: 10.1097/00000478-200412000-00001. PMID 15577672
- BACKGROUNDLughezzani G, Jeldres C, Isbarn H, Shariat SF, Sun M, Pharand D, Widmer H, Arjane P, Graefen M, Montorsi F, Perrotte P, Karakiewicz PI. A critical appraisal of the value of lymph node dissection at nephroureterectomy for upper tract urothelial carcinoma. Urology. 2010 Jan;75(1):118-24. doi: 10.1016/j.urology.2009.07.1296. Epub 2009 Oct 28. PMID 19864000
- BACKGROUNDKondo T, Nakazawa H, Ito F, Hashimoto Y, Toma H, Tanabe K. Primary site and incidence of lymph node metastases in urothelial carcinoma of upper urinary tract. Urology. 2007 Feb;69(2):265-9. doi: 10.1016/j.urology.2006.10.014. PMID 17320661
- BACKGROUNDKondo T, Hara I, Takagi T, Kodama Y, Hashimoto Y, Kobayashi H, Iizuka J, Omae K, Ikezawa E, Yoshida K, Tanabe K. Possible role of template-based lymphadenectomy in reducing the risk of regional node recurrence after nephroureterectomy in patients with renal pelvic cancer. Jpn J Clin Oncol. 2014 Dec;44(12):1233-8. doi: 10.1093/jjco/hyu151. Epub 2014 Sep 30. PMID 25271269
- Tanaka N, Kikuchi E, Kanao K, Matsumoto K, Kobayashi H, Ide H, Miyazaki Y, Obata J, Hoshino K, Shirotake S, Akita H, Kosaka T, Miyajima A, Momma T, Nakagawa K, Hasegawa S, Nakajima Y, Jinzaki M, Oya M. Metastatic behavior of upper tract urothelial carcinoma after radical nephroureterectomy: association with primary tumor location. Ann Surg Oncol. 2014 Mar;21(3):1038-45. doi: 10.1245/s10434-013-3349-z. Epub 2013 Nov 12.