Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417190
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer MIBC With Variant Histology
Sponsor:
Leslie Ballas
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
IIT2023-13-BALLAS-VHTMT Bladder Preservation for Patients With Muscle Invasive Bladder Cancer MIBC With Variant Histology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer MIBC with variant histology who receive neoadjuvant chemotherapy NAC with or without immunotherapy IO followed by trimodal therapy TMT Enrolled patients will undergo at least 3 cycles of NAC - IO oncologists choice followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC - IO and is therefore a viable option in patients who are risk of systemic disease spread
Detailed Description:
Trimodal therapy TMT is accepted as an NCCN category 1 alternative to radical cystectomy with neoadjuvant chemotherapy in patients with cT2N0M0 muscle-invasive urothelial cell bladder cancer MIBC Not all patients with MIBC have pure urothelial cell carcinoma urothelial carcinoma with variant histology VH described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor Variant histologies described include squamous differentiation glandular differentiation micropapillary sarcomatoid small cellneuroendocrine plasmacytoid and nested variant This is a rare tumor type and understudied For patients with variant histologies there is limited data on the use of trimodal therapy There are a couple single institution retrospective studies and data from the NCDB but no prospective data
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