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

Biliary Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464968
• Other study ID #: biliary second line
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2015
• Est. completion date: July 25, 2020

Study information

• Verified date: December 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 25, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Cancer Metastatic
• Biliary Tract Neoplasms

Intervention

Drug:
• Oxaliplatin,5FU, leucovorin
mFOLFOX
• irinotecan,5FU, leucovorin
mFOLFIRI

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 months overall survival rate	at 6 months from intervention treatment, overall survival rate	6months
Secondary	response rate	complete response, partial response	6months
Secondary	disease control rate	complete response, partial response, stable disease	6months
Secondary	progression free survival	from treatment start to progression or any cause of death	6months
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0	percentage of all patients	6months