Urothelial Carcinoma
Conditions
Keywords
Nephroureterectomy, Kidney and ureter, Upper Tract Urothelial Cell Carcinoma
Brief summary
The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are: * To determine oncologic outcomes, specifically 2-year recurrence-free survival * To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival * To determine time to recurrence and recurrence patterns * To determine use of adjuvant therapies * To determine perioperative complications Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
Detailed description
Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates
Interventions
PROCEDURENephroureterectomy
Participants will undergo standard-of-care nephroureterectomy for UTUC.
PROCEDURELymph Node Dissection
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is designed as a 1:1 two armed randomized-controlled trial.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 18 years * Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade) * Planned for nephroureterectomy by their urologic surgeon * Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis. * No concomitant muscle-invasive bladder cancer * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (\>cN0) * Presence of distant metastases * Concomitant muscle invasive bladder cancer * The participant is in a reduced general condition or has a life-threatening disease. * The participant has a psychiatric disorder that precludes them from understanding the consent process. * The patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 2 years post-op | Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-specific survival | 2 years post-op | Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND. |
| Overall Survival | 2 years post-op | Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND. |
| Treatment-free survival | 2 years post-op | Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND. |
| Use of adjuvant therapies | 2 years post-op | T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND. |
| Perioperative complications | 2 years post-op | T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND. |
| Time to recurrence | 2 years post-op | Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND. |
Countries
United States
Contacts
Primary ContactMohamed Eltemamy, MD
Backup ContactRebecca Campbell, MD
Outcome results
None listed