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

NCT03464968 | Completed Phase 2 DMC

• 1 other identifier: biliary second line
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Cancer Metastatic

Keywords

second line; FOLFOX; FOLFIRI

Outcome Measures

Primary Outcomes (1)

• 6 months overall survival rate

  at 6 months from intervention treatment, overall survival rate

  6months

Secondary Outcomes (4)

• response rate

  6months

• disease control rate

  6months

• progression free survival

  6months

• Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0

  6months

Study Arms (2)

mFOLFOX

EXPERIMENTAL

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

Drug: Oxaliplatin,5FU, leucovorin

mFOLFIRI

EXPERIMENTAL

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

Drug: irinotecan,5FU, leucovorin

Interventions

Oxaliplatin,5FU, leucovorin DRUG

mFOLFOX

mFOLFOX

irinotecan,5FU, leucovorin DRUG

mFOLFIRI

mFOLFIRI

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other cancer history
• pregnant or lactating
• uncontrolled medical condition such as infection or cardiovascular disease
• hypersensitivity to experimental drugs
• uncontrolled CNS metastasis, psychologic problem

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34303267 DERIVED

MeSH Terms

Interventions

Leucovorin

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 14, 2018
• Study Start: July 29, 2015
• Primary Completion: February 10, 2020
• Study Completion: July 25, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)