Nefro-ureterectomie met en zonder lymfeklierdissectie voor urotheelcelcarcinoom van het bovenste kanaal
Gerandomiseerd gecontroleerd onderzoek naar de oncologische en perioperatieve uitkomsten van nefro-ureterectomie met en zonder lymfeklierdissectie voor urotheelcelcarcinoom van het bovenste kanaal
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Mohamed Eltemamy, MD
- Telefoonnummer: 216-444-5888
- E-mail: Eltemam@ccf.org
Studie Contact Back-up
- Naam: Rebecca Campbell, MD
- Telefoonnummer: 216-444-1105
- E-mail: CAMPBER7@ccf.org
Studie Locaties
-
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Florida
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Gainesville, Florida, Verenigde Staten, 32209
- Werving
- University of Florida Health Science Center
-
Contact:
- Tarik Benidir, MD
-
Onderonderzoeker:
- Tarik Benidir, MD
-
-
Illinois
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Springfield, Illinois, Verenigde Staten, 62702
- Werving
- Southern Illinois University
-
Contact:
- Mohammad Mahmoud, MD
- E-mail: mmahmoud96@siumed.edu
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Hoofdonderzoeker:
- Mohammad Mahmoud, MD
-
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- Werving
- Cleveland Clinic Glickman Urological and Kidney Institute
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Contact:
- Mohamed Eltemamy, MD
- Telefoonnummer: 216-444-5888
- E-mail: Eltemam@ccf.org
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Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- 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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Hoofdonderzoeker:
- Adam Calaway, MD, MPH
-
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Recurrence-free survival
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment-free survival
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mohamed Eltemamy, MD, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
- Hoofdonderzoeker: Adam Calaway, MD, MPH, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CASE2824
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.
IPD-tijdsbestek voor delen
From when the trial starts (receives IRB approval and recruitment is initiated) until 1 year after the final participant finishes 2 year follow-up.
IPD-toegangscriteria voor delen
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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