Ignite Creation Date:
2024-05-06 @ 9:55 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03110510
Status:
WITHDRAWN
Last Update Posted:
2022-06-15
First Post:
2017-04-07
Brief Title:
FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer BTC Patients Who Were Failed After Gemcitabine Containing Chemotherapy A Phase II Single Arm Prospective Study
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
SAMSUNG MEDICAL CENTER
Status:
WITHDRAWN
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
institution problem
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
FOLFIRI as a salvage treatment in metastatic biliary tract cancer BTC patients who failed gemcitabine containing chemotherapy
Detailed Description:
Biliary tract carcinoma BTC is rare in the Europe and the United States but not uncommon in Asia and Latin America The tumor arises from the ductular epithelium of the biliary tree within the liver intrahepatic the extrahepatic ducts extrahepatic or the gallbladder Intrahepatic cancer is steadily increasing in the Western world BTCs carry a poor prognosis with 1-year survival rate of 25 Although surgery remains the only curative treatment for BTC most patients present with advanced disease and die within a few months of diagnosis While a combination of gemcitabine and platinum agents seems to be a conclusive treatment option as first-line treatment until now the role or the optimal regimen for second-line treatment has not been established
Few articles about second line treatment in advanced BTC were reported French group recently reported the retrospective analysis of FOLFIRI regimen in advanced BTC patients However there is no prospective trial of FOLFIRI regimen to evaluate the efficacy and safety in advanced BTC patients
So we plan this study to evaluate the efficacy and safety of FOLFIRI regimen as a second line treatment in biliary tract cancer
Few articles about second line treatment in advanced BTC were reported French group recently reported the retrospective analysis of FOLFIRI regimen in advanced BTC patients However there is no prospective trial of FOLFIRI regimen to evaluate the efficacy and safety in advanced BTC patients
So we plan this study to evaluate the efficacy and safety of FOLFIRI regimen as a second line treatment in biliary tract cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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