Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01267344
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2010-12-14
Brief Title:
A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin GEMOX With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer BTC
Status:
COMPLETED
Status Verified Date:
2013-10
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:
BTC
Brief Summary:
The primary objective is to investigate the objective response rate in patients receiving GEMOX gemcitabine plus oxaliplatin plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival biomarker prediction and toxicity
Detailed Description:
It is considered realistic that within 18 months 120 patients can be included in the participating centers Based on the previous publications an objective response rate ORR of 20 is expected in the GEMOX arm Arm B When the sample size of evaluable patients is between 110 and 120 evaluable patients ie 55 to 60 patients per treatment arm then a two-sided 95 confidence interval CI for the difference between an arm B response rate PB of 20 and an arm A response rate PA of 30 35 or 40 based on the large sample normal approximation will have a width between 154 and 167 We assume an objective response rate of 30 for Arm A then a two-sided 95 confidence interval CI for the difference between an arm B response rate PB of 20 and an arm A response rate PA of 30 will have a width 154 when the sample size of evaluable patients is 120 ie 60 patients per treatment arm
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