Status:
COMPLETED
mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Biliary Cancer Metastatic
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.
Detailed Description
1. brief enrollment criteria * histological confirmed * refractory to first line gemcitabine plus cisplatin * fit for chemotherapy 2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2...
Eligibility Criteria
Inclusion
- 20 years and older
- pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
- initially inoperable or recurrent
- ECOG 0-2
- as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
- evaluable or measurable lesion
- within 1 week, patients who meet below laboratory results (hemoglobin \>9.0 g/dL, neutrophil \>1000/uL, platelet\> 75000/uL, serum creatinine \< UNL \* 1.5, AST/ALT \< UNL\*3, total bilirubin \< UNL\*1.5 (available for biliary drainage)
- patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage
Exclusion
- other cancer history
- pregnant or lactating
- uncontrolled medical condition such as infection or cardiovascular disease
- hypersensitivity to experimental drugs
- uncontrolled CNS metastasis, psychologic problem
Key Trial Info
Start Date :
July 29 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03464968
Start Date
July 29 2015
End Date
July 25 2020
Last Update
December 2 2020
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620