Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493370
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-26
Brief Title:
Intravenous Ascorbate Plus GemcitabineCarboplatin A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Intravenous Ascorbate Plus GemcitabineCarboplatin A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a phase II single arm Simon two-stage design trial enrolling patients with cisplatin ineligible MIBC andor those patients who decline cisplatin based NAC
Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligibledeclined patients when IVC is added to gemcitabine-carboplatin NAC
Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligibledeclined patients when IVC is added to gemcitabine-carboplatin NAC
Detailed Description:
The investigator has hypothesized adding IVC to carbogem NAC will enhance pathological downstaging and improve QOL The patients eligible for this study cisplatin ineligible or declined with MIBC typically proceed straight to cystectomy within 12 weeks of initial diagnosis
In this study participants will receive two cycles of gemcitabinecarboplatin along with IVC and then proceed to cystectomy
In this study participants will receive two cycles of gemcitabinecarboplatin along with IVC and then proceed to cystectomy
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?:
False
Is an FDA AA801 Violation?:
None