mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line

Study Overview
=================
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
-----------------
brief enrollment criteria histological confirmed refractory to first line gemcitabine plus cisplatin fit for chemotherapy 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 randomization - stratified by tumor site and performance status

Official Title
-----------------
A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin

Conditions
-----------------
Biliary Cancer Metastatic

Intervention / Treatment
-----------------
* Drug: Oxaliplatin,5FU, leucovorin
* Drug: irinotecan,5FU, leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mFOLFOX<br>D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks | Drug: Oxaliplatin,5FU, leucovorin<br>* mFOLFOX<br>|
| Experimental: mFOLFIRI<br>D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks | Drug: irinotecan,5FU, leucovorin<br>* mFOLFIRI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months overall survival rate | at 6 months from intervention treatment, overall survival rate | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | complete response, partial response | 6months | 
| disease control rate | complete response, partial response, stable disease | 6months | 
| progression free survival | from treatment start to progression or any cause of death | 6months | 
| Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0 | percentage of all patients | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
second line, FOLFOX, FOLFIRI