Lymphadenectomy in Urothelial Carcinoma

NCT02607709 | Suspended DMC

• 1 other identifier: REG-79-2015
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ureteral Neoplasms

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  Five years

Secondary Outcomes (1)

• Incidence of metastasis

  Five years

Other Outcomes (1)

• Complications

  Within 30 days after operations

Study Arms (2)

Nephroureterektomy

PLACEBO COMPARATOR

scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy

Procedure: Nephroureterectomy without lymphadenectomy

Nephroureterektomy + Lymphadenectomy

EXPERIMENTAL

scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy

Procedure: Lymphadenectomy in conjugation with nephroureterectomy

Interventions

Lymphadenectomy in conjugation with nephroureterectomy PROCEDURE

Lymphadenectomy (intervention group only): Lymphadenectomy performs in four fractions on the right side and two fractions on the left side according to Dissection template (Appendix 1). Renal hilar nodes are included in fraction 1 and 3, respectively.

Nephroureterektomy + Lymphadenectomy

Nephroureterectomy without lymphadenectomy PROCEDURE

Removing the kidney, ureter and bladder cuff

Nephroureterektomy

Eligibility Criteria

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

You may qualify if:

• Age above 18 years
• Locally advanced high grade urothelial carcinoma in the renal pelvis or upper 2/3 of the ureter (Clinical stage \> T1)
• Patient with ECOG performance score of 2 and less.
• Able to give informed consent

You may not qualify if:

• Clinical suspicion of non-muscle invasive UUTUC
• Metastatic urothelial carcinoma for the renal pelvis or upper 2/3 of the ureter
• Inability to understand written consent forms or give consent

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Roskilde Hospital

Roskilde, 4000, Denmark

Location

Related Publications (8)

• Holmang 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 BACKGROUND

• Hall 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 BACKGROUND

• Olgac 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 BACKGROUND

• Lughezzani 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 BACKGROUND

• Kondo 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 BACKGROUND

• Kondo 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 BACKGROUND

• 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.

  PMID: 24217788 BACKGROUND

• 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. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Ureteral Neoplasms

Interventions

Lymph Node Excision; Nephroureterectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ureteral Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Nephrectomy; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Nessn H Azawi, MB.Ch.B.

  Roskilde University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 18, 2015
• Study Start: June 1, 2016
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

DK (1)