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FOLFIRINOX for 2nd-line Treatment of BTC

NCT03778593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-02-04

No results posted yet for this study

Summary

Biliary tract cancer (BTC) is rare in the West, but it is relatively high in Asia, including Korea. Currently used as the standard primary treatment in metastatic or locally advanced BTC is gemcitabine/platinum combination chemotherapy.There is no standard secondary chemotherapy recognized after the failure of the gemcitabine/platinum first line treatment. The investigators try to evaluate role of 5-FU, leucovorin, irinotecan, and oxaliplatin combination chemotherapy (FOLFIRINOX) for the patients who progressed after gemcitabine/cisplatin first line chemotherapy.

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

5-Fluorouracil

D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1L continuous IV over 23 hours q 2 weeks

DRUG

Leucovorin

D1 Leucovorin 400 mg/m2 + 5DW 200 ml mix IV over 2 hours q 2 weeks

DRUG

Irinotecan

D1 Irinotecan 135 mg/m2 + 5DW 500 mL mix IV over 2 hours (concurrent with the leucovorin infusion) q 2weeks

DRUG

Oxaliplatin

D1 Oxaliplatin 65 mg/m2 + 5DW 200 mL mix IV over 2 hours q 2 weeks

DRUG

5% dextrose water

mix fluid with 5-FU, leucovorin, irinotecan, and oxaliplatin

Sponsors & Collaborators

  • Dong-A University Hospital

    lead OTHER

Principal Investigators

  • Sung Yong Oh, M.D. · Dong-A University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-03-01
Completion
2021-01-14

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778593 on ClinicalTrials.gov