Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-26
Brief Title:
Partial Cystectomy Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer PRESERVE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal This clinical trial aims to determine the safety and oncologic efficacy of the intervention and to examine patient-reported quality of life outcomes in participants Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks After the pre-surgery treatment is completed participants will undergo a partial cystectomy with extended pelvic lymph node dissection After surgery participants will receive adjuvant systemic therapy
Detailed Description:
Radical cystectomy surgical removal of the bladder with pelvic lymph node dissection and urinary diversion with neoadjuvant chemotherapy in eligible participants is the standard of care in participants with muscle-invasive bladder cancer MIBC While this has demonstrated efficacy in the treatment of MIBC it has risk of perioperative morbidity and impacts quality of life Partial cystectomy surgical removal of a portion of the bladder is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life HRQOL while providing pathologic staging however there are limited data on outcomes with this treatment especially patient-reported HRQOL outcomes Additionally much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths Given these limitations in the existing literature the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection with standard of care perioperative systemic therapy in eligible participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None