Biliary Cancer Metastatic
Conditions
Keywords
second line, FOLFOX, FOLFIRI
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 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
Interventions
DRUGOxaliplatin,5FU, leucovorin
mFOLFOX
DRUGirinotecan,5FU, leucovorin
mFOLFIRI
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* other cancer history * pregnant or lactating * uncontrolled medical condition such as infection or cardiovascular disease * hypersensitivity to experimental drugs * uncontrolled CNS metastasis, psychologic problem
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 months overall survival rate | 6months | at 6 months from intervention treatment, overall survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response rate | 6months | complete response, partial response |
| disease control rate | 6months | complete response, partial response, stable disease |
| progression free survival | 6months | from treatment start to progression or any cause of death |
| Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0 | 6months | percentage of all patients |
Countries
South Korea
Outcome results
None listed