Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01234051
Status:
UNKNOWN
Last Update Posted:
2011-12-12
First Post:
2010-10-28
Brief Title:
Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor:
Korean South West Oncology Group
Organization:
Korean South West Oncology Group
Study Overview
Official Title:
Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Status:
UNKNOWN
Status Verified Date:
2010-11
Last Known Status:
RECRUITING
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:
1 Goals
The primary goal of this phase II trial is to
evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy
Secondary goals are toevaluate the treatment-related toxicities of this combination investigate progression-free survival PFS and overall survival OS in this population
2 Design
The proposed clinical trial is an open label non-comparative multicenter phase II trial according to the two stage testing design by Simon22
The primary goal of this phase II trial is to
evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy
Secondary goals are toevaluate the treatment-related toxicities of this combination investigate progression-free survival PFS and overall survival OS in this population
2 Design
The proposed clinical trial is an open label non-comparative multicenter phase II trial according to the two stage testing design by Simon22
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None