Ureteral NeoplasmsNCT02607709
Lymphadenectomy in Urothelial Carcinoma
A study testing Lymphadenectomy in conjugation with nephroureterectomy and Nephroureterectomy without lymphadenectomy in people with Ureteral Neoplasms, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Neoplasms
- What is being tested?
- Lymphadenectomy in conjugation with nephroureterectomy and Nephroureterectomy without lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lymphadenectomy in Urothelial Carcinoma in the Renal Pelvis and Ureter
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.
Read the detailed description
Background:
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 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.
Hypothesis: Complete lymphadenectomy during nephroureterectomy because of invasive urothelial carcinoma may reduce the incidence of lymph nodes metastasis, local recurrence, distant metastasis and improve the cancer survival rate.
Purpose: To evaluate the influence of complete lymphadenectomy on recurrence and cancer specific survival rate compared to limited or no lymphadenectomy.
Primary endpoint/analysis: Recurrence free survival at five-year postoperative. Secondary endpoints: Incidence of lymph node metastases, local recurrence and/or distant metastasis, cancer specific and overall survival at one, three and five-year postoperative. Complications rate according to Clavien classification within the first thirty days postoperatively.
Another endpoint/analysis: Multivariate analysis of possible preoperative risk factors for lymph node metastases (tumour size, preoperative urinary cytology, lymph node enlargement on CT, PET-CT positivity) and postoperative risk factors for lymph node metastases (stage, grade, tumour diameter, presence of necrosis in the tumour (none; <10%; >10% of total tumour area), number of lymph nodes excised).
Design: Prospectively randomized to template based lymphadenectomy or not, in patients with clinically muscle-invasive UUTUC in the renal pelvis or upper 2/3 of the ureter. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 183 patients in each group. Group A will be scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy except for clinically enlarged. Group B will be scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy.
- Conditions
- Ureteral Neoplasms
- Being tested
- Lymphadenectomy in conjugation with nephroureterectomy, Nephroureterectomy without lymphadenectomy
- Medical subject headings
- Ureteral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphadenectomy in conjugation with nephroureterectomyProcedure or surgery
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.
Nephroureterectomy without lymphadenectomyProcedure or surgery
Removing the kidney, ureter and bladder cuff
| Study group | Role | What they receive |
|---|---|---|
| Nephroureterektomy | Placebo comparator | scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy Receives: Procedure: Nephroureterectomy without lymphadenectomy |
| Nephroureterektomy + Lymphadenectomy | Experimental | scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy Receives: Procedure: Lymphadenectomy in conjugation with nephroureterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Measured: Five years
Secondary outcomes (1)
Incidence of metastasis
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startJun 2016
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Slow inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ureteral NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessn Azawi, Zealand University Hospital
- Investigators
- Nessn H Azawi, MB.Ch.B., Study chair, Roskilde University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607709
- Sponsor's protocol ID
- REG-79-2015
- Status last verified
- Jan 2024
- First submitted
- 15 Nov 2015
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16406872Hall 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.
PubMed 9763077Olgac 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.
PubMed 15577672Lughezzani 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.
PubMed 19864000Kondo 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.
PubMed 17320661Kondo 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.
PubMed 25271269Tanaka 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.
PubMed 24217788Dindo 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.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphadenectomy in Urothelial Carcinoma in the Renal Pelvis and Ureter
- ClinicalTrials.gov ID
- NCT02607709
- Acronym / sponsor ID
- REG-79-2015
- Conditions
- Ureteral Neoplasms
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Slow inclusions
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
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 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.
Hypothesis: Complete lymphadenectomy during nephroureterectomy because of invasive urothelial carcinoma may reduce the incidence of lymph nodes metastasis, local recurrence, distant metastasis and improve the cancer survival rate.
Purpose: To evaluate the influence of complete lymphadenectomy on recurrence and cancer specific survival rate compared to limited or no lymphadenectomy.
Primary endpoint/analysis: Recurrence free survival at five-year postoperative. Secondary endpoints: Incidence of lymph node metastases, local recurrence and/or distant metastasis, cancer specific and overall survival at one, three and five-year postoperative. Complications rate according to Clavien classification within the first thirty days postoperatively.
Another endpoint/analysis: Multivariate analysis of possible preoperative risk factors for lymph node metastases (tumour size, preoperative urinary cytology, lymph node enlargement on CT, PET-CT positivity) and postoperative risk factors for lymph node metastases (stage, grade, tumour diameter, presence of necrosis in the tumour (none; <10%; >10% of total tumour area), number of lymph nodes excised).
Design: Prospectively randomized to template based lymphadenectomy or not, in patients with clinically muscle-invasive UUTUC in the renal pelvis or upper 2/3 of the ureter. One to one, controlled clinical trial. Patients will be randomly allocated into two groups, 183 patients in each group. Group A will be scheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy except for clinically enlarged. Group B will be scheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nephroureterektomy | Placebo comparator | Procedure: Nephroureterectomy without lymphadenectomyscheduled to receive routine standard open or robot assisted nephroureterectomy without lymphadenectomy |
| Nephroureterektomy + Lymphadenectomy | Experimental | Procedure: Lymphadenectomy in conjugation with nephroureterectomyscheduled to received mapped lymphadenectomy in conjugation with nephroureterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphadenectomy in conjugation with nephroureterectomyLymphadenectomy (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. | Procedure or surgery | Nephroureterektomy + Lymphadenectomy |
| Nephroureterectomy without lymphadenectomyRemoving the kidney, ureter and bladder cuff | Procedure or surgery | Nephroureterektomy |
Primary outcome
Recurrence free survival
Time frame: Five years
1 secondary outcome
Incidence of metastasis
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 16406872Holmang 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.
- Background: PubMed 9763077Hall 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.
- Background: PubMed 15577672Olgac 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.
- Background: PubMed 19864000Lughezzani 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.
- Background: PubMed 17320661Kondo 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.
- Background: PubMed 25271269Kondo 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.
- Background: PubMed 24217788Tanaka 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.
- Background: PubMed 15273542Dindo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nessn H Azawi, MB.Ch.B. study chair
Roskilde University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphadenectomy in conjugation with nephroureterectomy and Nephroureterectomy without lymphadenectomy in people with Ureteral Neoplasms, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607709, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.