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

Primary Purpose

Biliary Cancer Metastatic

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin,5FU, leucovorin
irinotecan,5FU, leucovorin
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Cancer Metastatic focused on measuring second line, FOLFOX, FOLFIRI

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

mFOLFOX

mFOLFIRI

Arm Description

D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

Outcomes

Primary Outcome Measures

6 months overall survival rate
at 6 months from intervention treatment, overall survival rate

Secondary Outcome Measures

response rate
complete response, partial response
disease control rate
complete response, partial response, stable disease
progression free survival
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
percentage of all patients

Full Information

First Posted
March 1, 2018
Last Updated
December 1, 2020
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03464968
Brief Title
mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 29, 2015 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
July 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Cancer Metastatic
Keywords
second line, FOLFOX, FOLFIRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mFOLFOX
Arm Type
Experimental
Arm Description
D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
Arm Title
mFOLFIRI
Arm Type
Experimental
Arm Description
D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin,5FU, leucovorin
Intervention Description
mFOLFOX
Intervention Type
Drug
Intervention Name(s)
irinotecan,5FU, leucovorin
Intervention Description
mFOLFIRI
Primary Outcome Measure Information:
Title
6 months overall survival rate
Description
at 6 months from intervention treatment, overall survival rate
Time Frame
6months
Secondary Outcome Measure Information:
Title
response rate
Description
complete response, partial response
Time Frame
6months
Title
disease control rate
Description
complete response, partial response, stable disease
Time Frame
6months
Title
progression free survival
Description
from treatment start to progression or any cause of death
Time Frame
6months
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
Description
percentage of all patients
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34303267
Citation
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.
Results Reference
derived

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

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