mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line
NCT ID: NCT03464968
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2015-07-29
2020-07-25
Brief Summary
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Detailed Description
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* histological confirmed
* refractory to first line gemcitabine plus cisplatin
* fit for chemotherapy
2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
3. randomization - stratified by tumor site and performance status
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mFOLFOX
D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
Oxaliplatin,5FU, leucovorin
mFOLFOX
mFOLFIRI
D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
irinotecan,5FU, leucovorin
mFOLFIRI
Interventions
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Oxaliplatin,5FU, leucovorin
mFOLFOX
irinotecan,5FU, leucovorin
mFOLFIRI
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* pregnant or lactating
* uncontrolled medical condition such as infection or cardiovascular disease
* hypersensitivity to experimental drugs
* uncontrolled CNS metastasis, psychologic problem
20 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Jin Won Kim
Clinical Associate Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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Choi IS, Kim KH, Lee JH, Suh KJ, Kim JW, Park JH, Kim YJ, Kim JS, Kim JH, Kim JW. A randomised phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. Eur J Cancer. 2021 Sep;154:288-295. doi: 10.1016/j.ejca.2021.06.019. Epub 2021 Jul 22.
Other Identifiers
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biliary second line
Identifier Type: -
Identifier Source: org_study_id