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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Official Title: SAMSUNG MEDICAL CENTER

Study ID: NCT03110510

Study Description

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.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Samsung Medical Center, Seoul, , Korea, Republic of

Contact Details

Name: joonoh park

Affiliation: SamsungMedicalCenter

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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