Néphrourétérectomie avec et sans dissection des ganglions lymphatiques pour le carcinome à cellules urothéliales des voies supérieures
Essai contrôlé randomisé examinant les résultats oncologiques et périopératoires de la néphrourétérectomie avec et sans dissection des ganglions lymphatiques pour le carcinome à cellules urothéliales des voies supérieures
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mohamed Eltemamy, MD
- Numéro de téléphone: 216-444-5888
- E-mail: Eltemam@ccf.org
Sauvegarde des contacts de l'étude
- Nom: Rebecca Campbell, MD
- Numéro de téléphone: 216-444-1105
- E-mail: CAMPBER7@ccf.org
Lieux d'étude
-
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Florida
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Gainesville, Florida, États-Unis, 32209
- Recrutement
- University of Florida Health Science Center
-
Contact:
- Tarik Benidir, MD
-
Sous-enquêteur:
- Tarik Benidir, MD
-
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Illinois
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Springfield, Illinois, États-Unis, 62702
- Recrutement
- Southern Illinois University
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Contact:
- Mohammad Mahmoud, MD
- E-mail: mmahmoud96@siumed.edu
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Chercheur principal:
- Mohammad Mahmoud, MD
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Recrutement
- Cleveland Clinic Glickman Urological and Kidney Institute
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Contact:
- Mohamed Eltemamy, MD
- Numéro de téléphone: 216-444-5888
- E-mail: Eltemam@ccf.org
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Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
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Contact:
- Adam Calaway, MD, MPH
- E-mail: Adam.Calaway@UHhospitals.org
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Chercheur principal:
- Adam Calaway, MD, MPH
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recurrence-free survival
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment-free survival
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mohamed Eltemamy, MD, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
- Chercheur principal: Adam Calaway, MD, MPH, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Carcinome
- Carcinome à cellules transitionnelles
- Procédures chirurgicales, opératoires
- Procédures chirurgicales urologiques
- Procédures chirurgicales urogénitales
- Néphrectomie
- Excision des ganglions lymphatiques
- Néphreréréterectomie
Autres numéros d'identification d'étude
- CASE2824
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.
Délai de partage 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.
Critères d'accès au partage 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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