Urothelial Carcinoma Clinical Trial
Official title:
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
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.
Status | Not yet recruiting |
Enrollment | 94 |
Est. completion date | January 1, 2029 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Glickman Urological and Kidney Institute | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence-free survival | Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND. | 2 years post-op | |
Secondary | Treatment-free survival | Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND. | 2 years post-op | |
Secondary | Cancer-specific survival | Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND. | 2 years post-op | |
Secondary | Overall Survival | Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND. | 2 years post-op | |
Secondary | Time to recurrence | Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND. | 2 years post-op | |
Secondary | Use of adjuvant therapies | 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. | 2 years post-op | |
Secondary | Perioperative complications | 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. | 2 years post-op |
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