Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05538663
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-08-25
Brief Title:
Intravesical BCG vs GEMDOCE in NMIBC
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer BRIDGE
Status:
RECRUITING
Status Verified Date:
2023-12
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:
BRIDGE
Brief Summary:
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer NMIBC patients treated with intravesical Gemcitabine Docetaxel GEMDOCE will result in a non-inferior event-free survival EFS compared to standard treatment with intravesical BCG The purpose of this study is to test whether Gemcitabine Docetaxel is a better or worse treatment than the usual BCG therapy approach The primary objective of this study is to determine the event free survival EFS of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine Docetaxel Secondary objectives are as follows to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE to determine the cystectomy free survival CFS of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE to determine the progression free survival PFS of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE
Detailed Description:
The primary objective of this study is to determine the event free survival EFS of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine Docetaxel Secondary objectives are as follows to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE to determine the cystectomy free survival CFS of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE to determine the progression free survival PFS of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180820 | NIH | None | None |
| NCI-2022-04864 | OTHER | NCI | httpsreporternihgovquickSearchU10CA180820 |