Nefroureterectomia con e senza dissezione linfonodale per carcinoma a cellule uroteliali del tratto superiore
Studio randomizzato e controllato che esamina gli esiti oncologici e perioperatori della nefroureterectomia con e senza dissezione linfonodale per carcinoma a cellule uroteliali del tratto superiore
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mohamed Eltemamy, MD
- Numero di telefono: 216-444-5888
- Email: Eltemam@ccf.org
Backup dei contatti dello studio
- Nome: Rebecca Campbell, MD
- Numero di telefono: 216-444-1105
- Email: CAMPBER7@ccf.org
Luoghi di studio
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Florida
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Gainesville, Florida, Stati Uniti, 32209
- Reclutamento
- University of Florida Health Science Center
-
Contatto:
- Tarik Benidir, MD
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Sub-investigatore:
- Tarik Benidir, MD
-
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Illinois
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Springfield, Illinois, Stati Uniti, 62702
- Reclutamento
- Southern Illinois University
-
Contatto:
- Mohammad Mahmoud, MD
- Email: mmahmoud96@siumed.edu
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Investigatore principale:
- Mohammad Mahmoud, MD
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Reclutamento
- Cleveland Clinic Glickman Urological and Kidney Institute
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Contatto:
- Mohamed Eltemamy, MD
- Numero di telefono: 216-444-5888
- Email: Eltemam@ccf.org
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Cleveland, Ohio, Stati Uniti, 44106
- Reclutamento
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
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Contatto:
- Adam Calaway, MD, MPH
- Email: Adam.Calaway@UHhospitals.org
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Investigatore principale:
- Adam Calaway, MD, MPH
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Nephroureterectomy With Lymph Node Dissection
Participants will undergo nephroureterectomy for UTUC and will receive LND. |
Participants will undergo standard-of-care nephroureterectomy for UTUC. Participants will receive lymph node dissection alongside nephroureterectomy for UTUC. |
|
Comparatore attivo: Nephroureterectomy Without Lymph Node Dissection
Participants will undergo nephroureterectomy for UTUC and will not receive LND. |
Participants will undergo standard-of-care nephroureterectomy for UTUC. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recurrence-free survival
Lasso di tempo: 2 years post-op
|
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment-free survival
Lasso di tempo: 2 years post-op
|
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Cancer-specific survival
Lasso di tempo: 2 years post-op
|
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Overall Survival
Lasso di tempo: 2 years post-op
|
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Time to recurrence
Lasso di tempo: 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. |
2 years post-op
|
|
Use of adjuvant therapies
Lasso di tempo: 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. |
2 years post-op
|
|
Perioperative complications
Lasso di tempo: 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. |
2 years post-op
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mohamed Eltemamy, MD, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
- Investigatore principale: Adam Calaway, MD, MPH, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CASE2824
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.
Periodo di condivisione IPD
From when the trial starts (receives IRB approval and recruitment is initiated) until 1 year after the final participant finishes 2 year follow-up.
Criteri di accesso alla condivisione IPD
This will be shared with the following people at UH PI, research coordinator, residents/fellows/other attendings who are included on the IRB at UH.
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