Clinical trial NCT03464968: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Cancer Metastatic
Keywords: second line
FOLFOX
FOLFIRI
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

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

Primary outcomes:
measure: 6 months overall survival rate
timeFrame: 6months
Secondary outcomes:
measure: response rate
timeFrame: 6months
measure: disease control rate
timeFrame: 6months
measure: progression free survival
timeFrame: 6months
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
timeFrame: 6months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
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.