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Completed

NCT Number: NCT03464968

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

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.

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Key information

Conditions

Biliary Cancer Metastatic

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

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

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin,5FU, leucovorin

Drug

mFOLFOX

irinotecan,5FU, leucovorin

Drug

mFOLFIRI

Primary outcomes

  1. 6 months overall survival rate

    Time frame: 6months

    at 6 months from intervention treatment, overall survival rate

Secondary outcomes

  1. response rate

    Time frame: 6months

    complete response, partial response

  2. disease control rate

    Time frame: 6months

    complete response, partial response, stable disease

  3. progression free survival

    Time frame: 6months

    from treatment start to progression or any cause of death

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

    Time frame: 6months

    percentage of all patients

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2018
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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